MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS TIBIAL POLY BEARING 16MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer 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.Additional associated products & mdrs (b)(4) ti oss lkg axle cap and scrw lot# unk mdr: 0001825034-2023-00311 (b)(4) ti oss poly tib bushing set lot# unk mdr: 0001825034-2023-00312 (b)(4) ti oss 7cm rt sgmt dstl fmr lot# unk mdr: 0001825034-2023-00340 associated product (b)(4) ti oss 67mm mod tib bsplt lot# unk.
Event or Problem Description
It was reported the patient's knee is unstable due to varus/valgus stress and it appears the axle, yoke, and/or femoral bushings have failed.It is noted the patient is planned to be revised.Attempts to gather additional information are underway but no additional information is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified sign of use with nicks, worn and gouges.Review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Radiographs were provided, but not reviewed as poly wear is not visible via x-ray.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.
Additional Manufacturer Narrative
The product has been received by zimmerbiomet.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs 150477  oss poly femoral bushings lot# unk mdr: 0001825034-2023-00312.Additional associated products: cp0002527 ti oss reinforced yoke lot# unk.Cp0002528 ti oss lkg axle cap and scrw lot# unk.Cp0002525 ti oss 7cm rt sgmt dstl fmr lot# unk.
Event or Problem Description
It was reported that the patient was revised due to the knee being unstable to varus/valgus stress.The bearing and bushings were revised, all other implants remained.No additional information available as multiple attempts were made; however, no further information was received.As no additional information has been received, we are unable to provide further information.

• Brand Name: OSS TIBIAL POLY BEARING 16MM
• 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: 16387082
• Report Number: 0001825034-2023-00310
• Device Sequence Number: 20238513
• Product Code: JDI
• UDI-Device Identifier: 00880304006485
• UDI-Public: (01)00880304006485(17)210804(10)093230
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2023
• 2 Devices were Involved in the Event: 1 2

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: 08/04/2021
• Device Model Number: N/A
• Device Catalogue Number: 150412
• Device Lot Number: 093230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/20/2023
• Supplement Date Received by Manufacturer: 02/20/2023; 06/30/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 06/28/2023; 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2016
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male