MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNG UNV 5IN1 TIB TRL; INSTRUMENT KNEE

Model Number N/A

Device Problems Corroded (1131); Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Ji 8/23 it was reported that the device fractured.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

(b)(4) g2: (b)(6) h3: reporter had indicated that product will not be returned.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Other.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: reported event was confirmed by review of pictures provided.Visual evaluation of the provided pictures shows the device is fractured.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.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
• Type of Device: 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: 17585413
• MDR Text Key: 321815195
• Report Number: 0001825034-2023-01929
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00880304443709
• UDI-Public: (01)00880304443709(10)ZB6995886
• Combination Product (y/n): N
• Reporter Country Code: NT
• PMA/PMN Number: K113550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

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 Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32-483860
• Device Lot Number: ZB6995886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/09/2023
• Initial Date FDA Received: 08/21/2023
• Supplement Dates Manufacturer Received: 10/27/2023
• Supplement Dates FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1