MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CRUCIATE RETAINING TIBIAL BEARING 10MM X 63/67MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Degraded (1153); Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty revision to address polyethylene wear and tibial subsidence accompanied by pain approximately eleven (11) years post-operatively.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - biomet tinbn coated vanguard knee cruciate retaining femur right 60mm catalog #: 183004tnbn lot #: 3253337, biomet polished finned 1 piece tibial tray catalog #:141252tnbn lot #: 2013100675, biomet series a thin 3 peg patella 31mm catalog #: 184784 lot #: 071900 g2: foreign - event occurred in australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.The following sections were corrected: a1, d4, h6.The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.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
No further event information available at the time of this report.

• Brand Name: VANGUARD CRUCIATE RETAINING TIBIAL BEARING 10MM X 63/67MM
• 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: 23727024
• Report Number: 0001825034-2025-03875
• Device Sequence Number: 10641184
• Product Code: JWH
• UDI-Device Identifier: 00880304271050
• UDI-Public: (01)00880304271050(17)190415(10)827790
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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
• Report Date (Section B): 01/02/2026

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: Lay User/Patient
• Device Expiration Date: 04/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 183420
• Device Lot Number: 827790
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2014
• 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: Hospitalization; Required Intervention
• Patient Sex: Female