MAUDE Adverse Event Report: ZIMMER BIOMET, INC. REGENEREX 3 PEG SER A PATELLA 34MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Date of Event	03/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a right total knee arthroplasty.Subsequently, the patient developed pain and ambulation difficulties, and patella prosthesis fracture was noted on xray.Patient was revised approximately eight years post-implantation.During the revision, blackened synovitis and mechanical loosening of the patella were noted.All other components were found to be intact and remained implanted.No further adverse events were reported.
Additional Manufacturer Narrative
(b)(4).D10 medical devices: vngd ps open por fmrl rt 67.5, catalog #: 184510, lot #: 925210.Bmet regenx pri tib tray 75mm cocr 75mm, catalog #: 141274, lot #: 061060.E1 vngd cr tib brg 79/83x10, catalog #: ep-183460, lot #: 747040.Biomet finned pri stem 40mm, catalog #: 141314, lot #: 300520.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b4, g3, g6, h2, h3, h6, and h11.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tka was performed.The patient developed pain and difficulty ambulating with clicking noises.An x-ray showed broken pegs on the patella.During the revision the patella was loose, with blackened synovitis.The patella was explanted and replaced.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h11 h6: cause not established is n/a which was reported on initial report.Visual examination of the provided pictures identified the patient's incision site, which is being described as swelling in the knee by the patient.Pictures from the revision show the explanted patella with fragments retrieved and shown on the table.The root cause of the patella peg fracture was determined to be a labeling and training deficiency.Additional medical records review indicates the patient had a right knee aspiration and steroid injection due to pain and swelling, where the patient was diagnosed with patellar tendonitis.Additional office visits indicate pain with the decision to revise.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that patient underwent a right total knee arthroplasty.Patient had a knee aspiration and steriod injection due to pain and swelling and that pt later was diagnosed with patellar tendonities.Subsequently, the patient developed pain and ambulation difficulties, and patella prosthesis fracture was noted on xray.Patient was revised approximately eight years post-implantation.During the revision, blackened synovitis and mechanical loosening of the patella were noted.All other components were found to be intact and remained implanted.No further adverse events were reported.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.

• Brand Name: REGENEREX 3 PEG SER A PATELLA 34MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19518838
• Report Number: 0001825034-2024-01556
• Device Sequence Number: 20353755
• Product Code: JWH
• UDI-Device Identifier: 00880304554429
• UDI-Public: (01)00880304554429(17)210816(10)439580
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/16/2021
• Device Model Number: N/A
• Device Catalogue Number: 141357
• Device Lot Number: 439580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 11/06/2024; 03/12/2025; 05/19/2025
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 11/14/2024; 04/02/2025; 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 104 KG