MAUDE Adverse Event Report: BIOMET UK LTD. OXF FIX LAT BRG C4 RIGHT; UNICONDYLAR KNEE PROSTHESIS

Model Number	N/A
Medical Device Problem Codes	Degraded (1153); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report.Unique identifier (udi) number: (b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
The patient was revised due to insufficient medial collateral ligament (mcl), but when the surgeon saw the implant he was concerned about how much wear occurred to the oxford fixed lateral bearing in just 6 months.
Additional Manufacturer Narrative
(b)(4).Upon reassessment of the reported event, it was determined that the mdr report should not have been submitted under the current manufacturer.This event will be reported by medwatch facility warsaw biomet - (b)(4).Therefore, biomet uk ltd.Will not be sending any follow-ups regarding this product.
Event or Problem Description
The patient was revised due to insufficient medial collateral ligament (mcl), but when the surgeon saw the implant he was concerned about how much wear occurred in just 6 months to the oxford fixed lateral bearing.

• Brand Name: OXF FIX LAT BRG C4 RIGHT
• Common Device Name: UNICONDYLAR KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend
• MDR Report Key: 11026920
• Report Number: 3002806535-2020-00545
• Device Sequence Number: 667973
• Product Code: NRA
• UDI-Device Identifier: 05019279515554
• UDI-Public: 05019279515554
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 154361
• Device Lot Number: 052960
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 02/11/2021
• 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