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

Model Number	N/A
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	12/02/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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 or Problem Description
No further event information available at the time of this report.
Additional 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
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11398770
• Report Number: 0001825034-2021-00602
• Device Sequence Number: 1283562
• Product Code: HRY
• UDI-Device Identifier: 05019279515554
• UDI-Public: (01)05019279515554(17)240407(10)052960
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K133940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 04/22/2021; 05/10/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 05/10/2021; 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 62