MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS TIBIAL POLY BEARING 22MM; PROSTHESIS, KNEE

Catalog Number	150415
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); Scar Tissue (2060)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was revised due to stiffness/ scar tissue one year, eight months post initial implantation.Attempts have been made and no additional information has been provided.
Additional Manufacturer Narrative
(b)(4).D10 150415 oss tibial poly bearing 22mm lot# 65699858, 150480 oss axle lot# 65816545, 150493 oss reinforced yoke lot# 66130092, 150477 oss poly femoral bushings lot# 66205639, 150476 oss poly tibial bushing lot# 65733841, 150478 oss poly lock pin lot# 65889360.G2: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the facility.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.The following sections were updated/corrected updated: b4, b5, d5, g3, g6, h1, h2, h4, h6, h10, h11 the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient was revised due to fractured lock pin, pain, stiffness, and scar tissue release one year and seven months post implantation.
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; d2; g1; g3; g6; h1; h2; h3; h4; h6.The reported event was confirmed.No product was returned.Photograph was provided for explanted products and shows fractured lock pin with a part of it still stuck in the yoke.Evaluation for the other components could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OSS TIBIAL POLY BEARING 22MM
• 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: 22983639
• Report Number: 0001825034-2025-02801
• Device Sequence Number: 18499459
• Product Code: JDI
• UDI-Device Identifier: 00880304006508
• UDI-Public: (01)00880304006508(17)271121(10)65699858
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K002757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 150415
• Device Lot Number: 65699858
• 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: 08/15/2025
• Supplement Date Received by Manufacturer: 10/09/2025; 12/08/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 11/06/2025; 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2022
• 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: Required Intervention; Hospitalization
• Patient Sex: Female