MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD UNV 5IN1 TIB TRL 63/67X10; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Catalog Number	32-483820
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product has been returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a tasp was returned fractured.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5; d4; g3; h2; h4; h6 - visual inspection of the returned device exhibits signs of repeated use and part of the insertion and dovetail feature has fractured off.All pieces were not returned.Measurements taken were conforming.-review of device history records identified no related deviations or anomalies during manufacturing.- this device is used for treatment.- reported event is not related to a combination of products; therefore a compatibility review is not applicable.-review of complaint history identified additional similar complaints for the reported items and no additional complaints for part and lot combinations (for all time).-no medical records were provided.- the lot has been in the field for approximately 6+ years.It is unknown for how many times the device is being used.The root cause can be contributed to normal wear and tear of device.-no corrective actions, preventive actions, or field actions resulted after investigation of this event.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: VNGD UNV 5IN1 TIB TRL 63/67X10
• Common Device Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
• 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: 25347068
• Report Number: 0001825034-2026-01507
• Device Sequence Number: 20110073
• Product Code: JWH
• UDI-Device Identifier: 00880304443853
• UDI-Public: (01)00880304443853(10)Z19E1279
• Combination Product (Y/N): N
• 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: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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
• Device Catalogue Number: 32-483820
• Device Lot Number: Z19E1279
• Date Returned to Manufacturer: 05/11/2026
• 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: 05/08/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 06/01/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown