MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS RS POLY TIBIAL BEARING 14; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Catalog Number	161029
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	03/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2- spain.H3- customer has indicated that the product will 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.
Event or Problem Description
It was reported that a patient was revised approximately eight years and five months post implantation due to fracture of the polyethylene component and a fracture of the extensor mechanism caused by the fractured and dislocated polyethylene.The patient experienced pain and instability.Attempts to obtain additional information have been made; however, no more information is available.
Event or Problem Description
No further event information is 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; d9; g3; h2; h3; h6 complaint sample was evaluated, and the reported event was confirmed.Visual examination of the returned component identified signs of repeated use (nicked/gouged), and the bearing had a piece fractured off.The fractured piece was not returned.Physical dimensions could not be measured due to the damage.The device was sent for fracture analysis; the inferior surface of the bearing showed evidence of possible delamination and/or oxidation and cracking, especially on both edges and near the channel for the oss yoke.There was also evidence of possible plastic deformation in the channel for the yoke, possibly from high loading on the bearing from the yoke during high flexion.The timeline of the item fractures could not be stated with certainty since no further details were provided, but it was suspected that overloading, especially around the posterior side of the bearing potentially led over time to high oxidation and the associated wear and delamination, which increased the brittleness and decreased the strength of the bearing, leading to increased potential of a fracture.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 RS POLY TIBIAL BEARING 14
• Common Device Name: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
• 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: 24744949
• Report Number: 0001825034-2026-00793
• Device Sequence Number: 9422434
• Product Code: KRO
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/05/2021
• Device Catalogue Number: 161029
• Device Lot Number: 988590
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2016
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown