MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD TIBIAL BEARING POSTERIOR STABILIZED (PS); PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a total knee arthroplasty, the surgeon had a hard time inserting the locking bar to the bearing.Due to this, he forcefully inserted the locking bar, and he heard snap sound and something like a piece of bearing came out.As a result, the operation was completed with another articular surface.According to the surgeon, there was no breakage on the bearing.The piece might be a cement particle.The surgical technique was utilized.There was no surgical delay.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 141232 - biomet cc cruciate tray 67mm - j7727132.G2 : foreign country : japan.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d9; g1; g3; g6; h1; h2; h3; h6; h10 the event cannot be confirmed.Visual examination of the returned product identified found minor nicks/dings and the bearing shows little to no signs of use and is not fractured.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.A definitive root cause cannot be determined.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 available at the time of this report.

• Brand Name: VANGUARD TIBIAL BEARING POSTERIOR STABILIZED (PS)
• 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: 20622212
• Report Number: 0001825034-2024-02612
• Device Sequence Number: 15679844
• Product Code: JWH
• UDI-Device Identifier: 00889024565593
• UDI-Public: (01)00889024565593(17)290623(10)66775324
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/11/2025

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: VE183620
• Device Lot Number: 66775324
• 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: 10/18/2024
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2024
• 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.
• Patient Sex: Unknown