MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN VANGUARD TIBIAL BEARING 10MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Insufficient Information (4580)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - unknown biomet tibial component catalog #: ni lot #: ni, unknown vanguard femoral component catalog #: ni lot #: ni.G2 - report source - foreign: event occurred in australia.The complainant has not yet indicated whether 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 the patient underwent a knee arthroplasty revision of the tibial bearing to address unknown complications approximately fifteen (15) years post-operatively.Attempts have been made; however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a1, a3, b1, b4, b5, b7, d1, d4, d11, g3, g6, h2, h6, h11.
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty revision of the tibial bearing to address synovitis and polyethylene wear approximately fifteen (15) years post-operatively.Initial operative notes noted no intraoperative complications.Revision notes noted synovitis, which was addressed with a near total synovectomy.Upon removal of the polyethylene tibial insert, the implant was noted to have extensive polyethylene wear posteromedially and to an extent posterolaterally.A new polyethylene implant was placed and no intraoperative complications were noted.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a2, b4, b5, g3, g6, h2, h3, h6, h11.D4: attempts have been made to gather all product identification information and no further information has been provided.Visual evaluation of pictures provided identified that the articular surface exhibited wear and was covered in foreign debris consistent with explantation.Medical records provided confirmed the reported event.The device history records could not be reviewed as the lot number associated with the reported event is unknown.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
It was reported that the patient underwent a knee arthroplasty revision of the tibial bearing to address pain, synovitis and polyethylene wear approximately fifteen (15) years post-operatively.Initial operative notes noted no intraoperative complications.Revision notes noted synovitis, which was addressed with a near total synovectomy.Upon removal of the polyethylene tibial insert, the implant was noted to have extensive polyethylene wear posteromedially and to an extent posterolaterally.A new polyethylene implant was placed and no intraoperative complications were noted.Attempts have been made; however, no additional information is available.

• Brand Name: UNKNOWN VANGUARD TIBIAL BEARING 10MM
• 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: 22193240
• Report Number: 0001825034-2025-01709
• Device Sequence Number: 15780569
• Product Code: JWH
• UDI-Device Identifier: 00880304436954
• UDI-Public: (01)00880304436954(17)300217(10)67133014
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 189082
• Device Lot Number: 67133014
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 06/18/2025; 07/11/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/10/2025; 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2025
• 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; SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male