MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD UNIVERSAL CR PROVISIONAL TIBIAL BEARING 10MM X 71/75MM; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during knee arthroplasty the polyethylene tibial trial fractured upon removal.No adverse events were reported as a result of this malfunction.
Additional Manufacturer Narrative
(b)(4).Visual evaluation of the returned instrument identified signs of repeated use (nicks, gouges, wear) and a piece was confirmed to have fractured off from the posterior surface.The device was noted to be conforming where measured.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.

• Brand Name: VANGUARD UNIVERSAL CR PROVISIONAL TIBIAL BEARING 10MM X 71/75MM
• Common Device Name: INSTRUMENT, 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: 21433869
• Report Number: 0001825034-2025-00427
• Device Sequence Number: 14537291
• Product Code: JWH
• UDI-Device Identifier: 00887868490811
• UDI-Public: (01)00887868490811(11)220514(10)ZB7251631
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K113550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32-483740
• Device Lot Number: ZB7251631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2024
• 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: 02/11/2025
• Initial Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown