MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD PS+ TIB BRG 14X87/91MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 01/06/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent total knee arthroplasty.Subsequently, approximately 4 years and two months post procedure the patient underwent a revision procedure due to the ps tibial bearing post fracturing.

Event Description

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

Manufacturer Narrative

No product was returned; dimensional evaluations could not be performed.Photographs of the explanted product confirm that the bearing post was fractured from the device.Review of the device history record identified no related deviations or anomalies during manufacturing.No medical records were provided.This complaint is confirmed.Root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.

• Brand Name: VNGD PS+ TIB BRG 14X87/91MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11246773
• MDR Text Key: 229595478
• Report Number: 0001825034-2021-00275
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNK BEARING
• Device Lot Number: 412940
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2021
• 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
• Patient Weight: 152