MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNG UNV 5IN1 TIB TRL 71/75X10; PROSTHESIS, KNEE

Catalog Number	32-483840
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a tasp fractured during surgery.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
(b)(4).H3- customer has indicated that the product will not 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
No further event information available at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: b4, b5, d2b, g1, g3, g6, h1, h2, h3, h4, h6, and h11.Visual examination of the provided pictures identified a tibial trial device covered in bio-debris with the part and lot information identifiable.The reported event can be confirmed as the device was fractured.No product was returned therefore no further evaluations can be made.Medical records were not provided.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.This complaint is confirmed.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: VNG UNV 5IN1 TIB TRL 71/75X10
• 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: 23768463
• Report Number: 0001825034-2025-03930
• Device Sequence Number: 15888499
• Product Code: JWH
• UDI-Device Identifier: 00880304443730
• UDI-Public: (01)00880304443730(10)Z19A1859
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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: 32-483840
• Device Lot Number: Z19A1859
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown