MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD FMRL/TIB IMPACTOR; INSTRUMENT KNEE

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 03/29/2022

Event Type  malfunction  

Event Description

It was reported that the device was fractured post-surgery.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

(b)(4).The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.

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.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows signs of use and is fractured.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to wear and tear.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 FMRL/TIB IMPACTOR
• Type of Device: INSTRUMENT KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14237915
• MDR Text Key: 290405696
• Report Number: 0001825034-2022-00986
• Device Sequence Number: 1
• Product Code: HXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• 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: 32-486201
• Device Lot Number: ZB160702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2016
• 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