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

Model Number N/A

Device Problems Degraded (1153); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Type  Injury  

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 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.

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 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
• Type of Device: UNICONDYLAR KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend
• MDR Report Key: 11026920
• MDR Text Key: 222012603
• Report Number: 3002806535-2020-00545
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279515554
• UDI-Public: 05019279515554
• 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
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 154361
• Device Lot Number: 052960
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2021
• 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