MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET OFFSET TIBIAL TRAY 63MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient is experiencing pain and stiffness approximately six (6) months following knee arthroplasty.Initial operative notes noted no intraoperative complications.Attempts have been made; however, no additional information is available.
Additional Manufacturer Narrative
(b)(4) d10 - concomitant devices - vanguard ssk femoral implant with screw 60mm left catalog #: cp113123 lot #: 66529561, vanguard ssk tibial bearing 22mm x 63/67mm catalog #: 183832 lot #: 929580, biomet smooth knee stem 16mm x 80mm catalog #: 145026 lot #: 161830, biomet smooth knee stem 12mm x 40mm catalog #: 145002 lot #: 66366323, persona cemented all poly patella 32mm catalog #: 42540000032 lot #: 66187751, persona tibial central cone size x-small catalog #: 42545000510 lot #: 66948841.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.This report was previously submitted erroneously on oct 1, 2025, oct 23, 2025, and dec 19, 2025, under manufacturing report number 0001822565-2025-03624.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h10, h11.The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.The vanguard implants were found to be incompatible with the retained persona implants, however, it is unknown whether the incompatibility contributed to the reported event and a definitive root cause could not be determined with the information provided.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.

• Brand Name: BIOMET OFFSET TIBIAL TRAY 63MM
• 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: 23943969
• Report Number: 0001825034-2026-00005
• Device Sequence Number: 20791016
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 141481
• Device Lot Number: 65745839
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2023
• 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 H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 130 LB