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

Model Number N/A

Device Problem Crack (1135)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2021

Event Type  malfunction  

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

It was reported that the device pad was discovered to be cracked.Attempt for further information has been made, but no further information has been provided.

Event Description

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

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned device exhibited signs of wear and the end exhibits strike marks and the poly piece has cracked and is still intact as one piece.Device history record (dhr) was reviewed and no discrepancies were found.The root cause is determined as normal 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: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11280379
• MDR Text Key: 230613716
• Report Number: 0001825034-2021-00308
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• 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: ZB140702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1