MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD VE PS TIB BRG 79/83X11MM; PROSTHESIS, KNEE

Catalog Number	VE183661
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after installing the bearing, the locking bar didn't go straight in and could not be seated in the tibial tray.Staff noticed that the bottom surface of the bearing was not flat and it tilted like a seesaw when placed on the tibial tray.The surgery was completed with another device.The surgical technique was utilized.There was less than a 30 minute delay.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: (b)(6) - biomet cc cruciate tray 79mm - (b)(6).G2: foreign country: japan.Product has been received by zimmer biomet and the investigation is in process.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; g1; g3; g6; h1; h2; h3; h6.The event is confirmed.Visual inspection of the returned device was performed.Verified product identifiers.Product exhibits signs of use (gouge on the bottom surface).There is a raised surface on the bottom, near the anterior slot between the notches and a possible gouge in the bottom middle of the anterior slot as well.Performed dimensional analysis and results were found to be within specification.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.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 VE PS TIB BRG 79/83X11MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23715983
• Report Number: 0001822565-2025-04386
• Device Sequence Number: 10260561
• Product Code: JWH
• UDI-Device Identifier: 00889024565746
• UDI-Public: (01)00889024565746(17)271026(10)65667878
• 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): 03/30/2026

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 Catalogue Number: VE183661
• Device Lot Number: 65667878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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