Table of contents
- Latest Biomet Shoulder Replacement Lawsuit Updates
- May 8, 2024: FDA Ends Shoulder System Recall
- July 24, 2023: Fifth Circuit Lets Shoulder Implant Suit Continue
- March 9, 2023: FDA Ends Mislabeled Screw Recall
- May 6, 2020: FDA Ends Baseplate Recall
- August 29, 2017: FDA Ends Humeral Tray Recall
- February 16, 2017: MD+DI Reports Class I Classification
- February 11, 2017: FDA Posts Humeral Tray Recall
- February 1, 2017: Second Notice Adds Product Lots
- December 20, 2016: Zimmer Biomet Starts Lot-Specific Recall
- February 21, 2013: FDA Ends 2011 Humeral Tray Recalls
- April 22, 2011: Biomet Starts Class 2 Locking Ring Recall
- What Is the Comprehensive Reverse Shoulder System?
- Who May Be Affected?
- Reported Injuries or Damages
- Recall and Regulatory Background
- Evidence to Preserve
- Filing Deadlines
- Frequently Asked Questions
- What Does the Research Say About Shoulder Implant Breakage?
- Do Reverse and Anatomic Shoulder Implants Break at Different Rates?
- Has a Court Ruled in a Biomet Shoulder Replacement Lawsuit?
- How Can I Tell If My Shoulder Implant Was Recalled?
Zimmer Biomet recalled 4,388 Comprehensive Reverse Shoulder System humeral trays after a higher than anticipated rate of fracturing due to design. The FDA classified the 2016 recall as Class I.
A fracture can lead to revision surgery. The FDA said that surgery could cause permanent loss of shoulder function, infection or, rarely, death. A Fifth Circuit case involves a Biomet and Zimmer implant that allegedly became infected and was removed.
Only individual product liability claims exist. No MDL or class action has been filed. The devices were made between Aug. 25, 2008 and Sept. 27, 2011 and distributed between October 2008 and September 2015.
Latest Biomet Shoulder Replacement Lawsuit Updates
May 8, 2024: FDA Ends Shoulder System Recall
The FDA terminated Class 2 recall Z-0619-2021 on May 8, 2024 [1]. Zimmer Biomet had initiated the action on November 25, 2020.
The recall involved 7,428 Comprehensive Reverse Shoulder System units. Specific lots of multiple sterile medical devices may have a breach in the sterile seal.
July 24, 2023: Fifth Circuit Lets Shoulder Implant Suit Continue
Law360 reported that a Fifth Circuit panel will let a man pursue his product liability suit [2]. He alleges a prosthetic with parts manufactured by Biomet Inc. and Zimmer Inc. became infected and was ultimately removed.
The ruling leaves a jury to decide whether he brought his claims quickly enough. The infection claim is an allegation, and no finding of liability has been reported.
March 9, 2023: FDA Ends Mislabeled Screw Recall
The FDA terminated Class 2 recall Z-1131-2021 on March 9, 2023 [3]. Zimmer Biomet had initiated it on January 15, 2021. A 40 MM central screw was packaged and labeled as 25 MM. The recall involved 49 units.
May 6, 2020: FDA Ends Baseplate Recall
Class 2 recall Z-0972-2019 was terminated by the FDA on May 6, 2020 [4]. Zimmer Biomet began it on December 21, 2018. The Glenosphere Mini Baseplate was potentially packaged without a taper adapter. It involved 52 units.
August 29, 2017: FDA Ends Humeral Tray Recall
The FDA terminated Class I recall Z-1103-2017 on August 29, 2017 [5]. The recall covered the Comprehensive Reverse Shoulder System Humeral Tray, Model 115340.
February 16, 2017: MD+DI Reports Class I Classification
MD+DI reported that the FDA identified the Zimmer Biomet Comprehensive Reverse Shoulder recall as Class I, the most serious type of recall [6].
February 11, 2017: FDA Posts Humeral Tray Recall
The FDA posted the Zimmer Biomet humeral tray recall record as Recall Number Z-1103-2017 on February 11, 2017. The recalling firm is listed as Zimmer Biomet, Inc. of Warsaw, Indiana.
February 1, 2017: Second Notice Adds Product Lots
Zimmer Biomet sent a second urgent notice on February 1, 2017, to surgeons, risk managers and distributors. The notice added product lots to the recall. It also gave patient monitoring guidance for surgeons, per the FDA.
December 20, 2016: Zimmer Biomet Starts Lot-Specific Recall
Zimmer Biomet initiated a lot-specific recall of the Comprehensive Reverse Shoulder System Humeral Trays on December 20, 2016, per the FDA. Urgent medical device recall notices went to the affected risk managers and distributors by courier.
February 21, 2013: FDA Ends 2011 Humeral Tray Recalls
The FDA terminated the two 2011 Class 2 humeral tray recalls, Z-2550-2011 and Z-2543-2011, on February 21, 2013 [7]. Both recalls involved Comprehensive Reverse Shoulder humeral trays.
April 22, 2011: Biomet Starts Class 2 Locking Ring Recall
Biomet initiated a Class 2 recall of 1,575 Comprehensive Reverse Shoulder humeral trays on April 22, 2011, per the FDA. The company found a rare possibility that certain humeral trays may contain a locking ring that is incorrectly assembled.
What Is the Comprehensive Reverse Shoulder System?
According to the FDA recall database, Biomet Comprehensive Reverse Shoulder products are indicated for certain patients [8]. They have a grossly deficient rotator cuff with severe arthropathy and/or a previously failed shoulder joint replacement.
The FDA calls the humeral tray a semi-constrained, metal/polymer, cemented shoulder prosthesis. MD+DI says the devices are surgically implanted to help restore arm movement. The Model 115340 humeral tray in the 2016 recall is part of this system.
Who May Be Affected?
You may be affected if you received a Zimmer Biomet or Biomet Comprehensive Reverse Shoulder System Humeral Tray, Model 115340, from the recalled lots. The FDA lists the affected lot numbers.
Other circumstances include revision surgery after a fracture, or a shoulder implant that became infected or was removed. Whether a shoulder implant problem supports a claim is a question for an individual legal review.
Reported Injuries or Damages
The FDA said fractures may result in revision surgeries. These could cause serious adverse health consequences. The recall record states a risk of revision surgery due to fracturing. These statements describe risk and are not injury counts.
The plaintiff in the Fifth Circuit case alleges his implant became infected and was removed. That is an allegation, and no liability finding is reported.
A 2023 systematic review by Liebhauser and colleagues covered worldwide registries and clinical trials. It appeared in BMC Musculoskeletal Disorders. Overall fracture rates ranged from 9 to 6648 per 100,000 observation component years [9].
Recall and Regulatory Background
The FDA lists the cause of the 2016 recall as device design and the status as terminated. The company’s stated reason was fracturing at a higher rate than it anticipated.
The FDA lists five other Class 2 recalls of Comprehensive Reverse Shoulder parts, started between 2011 and 2021. A recall alone does not establish liability. For a different Zimmer implant, see the Zimmer Persona lawsuit page.
Evidence to Preserve
Keep these records and items. They can show which implant you received and what followed:
- The implant card or operative report showing the product name, model and lot number that the recall record lists
- Hospital and surgeon records, including any revision surgery or implant removal
- Imaging records and photographs of the shoulder and the implant
- Medical bills and insurance records for the implant and later treatment
- Letters and messages with the surgeon, hospital or Zimmer Biomet, including any recall notice
- A dated written record of your symptoms and any lost shoulder function
Filing Deadlines
State law sets the time limit for an injury claim. The limit differs with where you live and when you discovered your injury and its link to the implant.
A missed time limit can end a claim even if the facts are strong. That holds for a fracture, an infection or a revision surgery.
Frequently Asked Questions
What Does the Research Say About Shoulder Implant Breakage?
Research on shoulder implant breakage calls it a rare complication after shoulder arthroplasty. The 2023 systematic review found breakage in clinical studies ranged from 0.1 to 21.0%. The mean was 4.1%. Rates vary widely between studies.
Do Reverse and Anatomic Shoulder Implants Break at Different Rates?
Reverse and anatomic shoulder implants had different fracture rate ranges in the 2023 review. Anatomic total shoulder implants ranged from 9 to 6648. Reverse implants ranged from 17 to 3030. Both are rates per 100,000 observation component years.
Has a Court Ruled in a Biomet Shoulder Replacement Lawsuit?
A court has not found Biomet liable in a Biomet shoulder replacement lawsuit. Law360 reported that a Fifth Circuit panel let one suit continue, and a jury will decide whether the man filed in time. The infection claim remains an allegation.
How Can I Tell If My Shoulder Implant Was Recalled?
To tell if your shoulder implant was recalled, compare its model and lot numbers with the FDA recall record. Your implant papers can list them, and your surgeon or hospital can help you read them.