MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VANGUARD COMPLETE KNEE SYSTEM - ANT STBLZD BRG 14X79; PROSTHESIS, KNEE

Catalog Number 189104

Device Problems Delamination (2904); Naturally Worn (2988)

Patient Problems Pain (1994); No Information (3190)

Event Date 02/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown femur; unknown tibia.Customer has indicated that the product will not be returned, as it was retained by the hospital, to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent a left knee revision procedure approximately 11 years post implantation to exchange the tibial bearing due to unknown reasons.During the revision it was noted that the bearing was delaminated.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

It was reported that a patient underwent a left knee revision procedure approximately eleven years post implantation to exchange the tibial bearing due to pain and wear.During the revision it was noted that the bearing was delaminated.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).A photo of the bearing was received and review of the photo confirmed the presence of wear and the bearing appears to be delaminated, confirming the complaint.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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

It was reported that the patient had a left knee arthroplasty on approximately 11 years ago.Subsequently, the patient was revised due to unknown reasons on 2 years later and the tibial bearing was exchanged.The patient then underwent a second revision due to pain and poly wear approximately 9 months ago and the tibial bearing was exchanged a second time.

• Brand Name: VANGUARD COMPLETE KNEE SYSTEM - ANT STBLZD BRG 14X79
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6425586
• MDR Text Key: 70622487
• Report Number: 0001825034-2017-01987
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK113550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: 189104
• Device Lot Number: 728630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR