MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS TIBIAL POLY BEARING 12MM; PROSTHESIS, KNEE

Catalog Number	150410
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: cps nut co-cr-mo alloy: catalog#178512, lot#025940; cps 7cm seg fm oss tpr lt: catalog#178713, lot#243240; oss poly femoral bushings: catalog#150477, lot#365540; oss axle: catalog#150480, lot#361790; cps ellip spdl w pins 800lbf: catalog#178361, lot#877750; oss reinforced yoke: catalog#150493, lot#437040; oss poly lock pin: catalog#150478, lot#724830; oss poly tibial bushing: catalog#150476, lot#406200; cps anchor plug 22mm: catalog#178412, lot#752810; cps shrt centering sleeve 27mm: catalog#178737, lot#831060; cps transverse pin 6pk 36mm: catalog#178528, lot#070970.The product has been received by zimmer biomet and the investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent a revision knee procedure.Approximately two (2) years and six (6) months post-implantation, the patient began to experience instability.A revision procedure was performed in which the articular surface was found to be fractured.The affected bearing was replaced without reported complication.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h6; h11.Visual examination of the returned product identified signs of being implanted in the form of wear and discoloration along with the implant having cracks and torn edges.The device was submitted for further analysis.Analysis determined the inferior side shows some scuffing and possible gouging or abrasions that are typical with in-vivo use.In the pocket for the yoke, there appears to be plastic deformation and damage from yoke pentation into the uhwmpe material.The material between the yoke pocket and the keyway also has some plastic deformation in it and appears to have been subjected to a pushing force from the yoke.The superior side has some plastic deformation around the yoke just superior to where the yoke has penetrated into the bearing, and both sides of the bearing have been breached on the superior side.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.Complaint sample was evaluated and the reported event was confirmed.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.
Event or Problem Description
No further event information at time of this report.

• Brand Name: OSS TIBIAL POLY BEARING 12MM
• 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: 18582494
• Report Number: 0001825034-2024-00175
• Device Sequence Number: 15582926
• Product Code: JDI
• UDI-Device Identifier: 00880304239388
• UDI-Public: (01)00880304239388(17)270516(10)025680
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K002757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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 Catalogue Number: 150410
• Device Lot Number: 025680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2024
• 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: 01/04/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2022
• 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 H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 91 KG