MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OXFORD PARTIAL KNEE FIXED LATERAL TIBIAL CONSTRUCT RIGHT C4; PROSTHESIS, KNEE

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 12/02/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: oxford partial knee twin-peg femoral component catalog #: 166941 lot #: j6432239.Report source - foreign: (b)(6).The complainant has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.This report was previously submitted erroneously on dec 17, 2020 and feb 11, 2021 under manufacturing report number 3002806535-2020-00545.

Event Description

It was reported that the patient underwent a knee arthroplasty revision to address an insufficient medial collateral ligament (mcl) approximately seven (7) months post-operatively.During the procedure, the surgeon noted that the lateral bearing was significantly worn.Attempts have been made, however, no additional information is available at this time.

Event Description

It was reported that the patient underwent a knee arthroplasty revision to address mild instability of the medial collateral ligament (mcl) approximately seven (7) months post-operatively.During the procedure, the surgeon noted that the lateral bearing was significantly worn.Attempts have been made, however, no additional information is available at this time.

Event Description

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

Manufacturer Narrative

The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.Radiographs were reviewed and indicated that suspected malalignment of the lateral unicompartmental arthroplasty is noted which could result in bearing wear and early need for revision.Bone quality is osteopenic.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: OXFORD PARTIAL KNEE FIXED LATERAL TIBIAL CONSTRUCT RIGHT C4
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11398770
• MDR Text Key: 234247723
• Report Number: 0001825034-2021-00602
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 05019279515554
• UDI-Public: (01)05019279515554(17)240407(10)052960
• Combination Product (y/n): N
• PMA/PMN Number: K133940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2021

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: 04/07/2024
• Device Model Number: N/A
• Device Catalogue Number: 154361
• Device Lot Number: 052960
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 04/22/2021; 05/10/2021
• Supplement Dates FDA Received: 05/10/2021; 05/21/2021
• 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: 62