MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR LIP TIB BRG 12X63/67; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Failure of Implant (1924); Joint Laxity (4526)

Event Date 06/29/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source - foreign: eu: (b)(6).The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that there was severe wear of polyethylene bearing, resulting in instability.Revision surgery was done and changed bearing.Attempts for further information have been made; however, no further information is available.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Updated: b4, b5, g3, g6, h1, h2, h3, h6, and h10.The results of the investigation are as follows: -visual examination of the returned product found signs of being implanted wear/discoloration.- review of the device history record(s) identified no deviations or anomalies during manufacturing.-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.

Event Description

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

• Brand Name: VANGUARD CR LIP TIB BRG 12X63/67
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12225323
• MDR Text Key: 263406939
• Report Number: 0001825034-2021-02028
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2015
• Device Model Number: N/A
• Device Catalogue Number: 183522
• Device Lot Number: 2014083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/26/2021
• Supplement Dates Manufacturer Received: 08/03/2021
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention