MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZA RM; KNEE PROSTHESIS

Catalog Number 154719

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 01/17/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - associated medical devices: oxf anat brg rt md size 4 pma; item# 159576; lot# 486180.Oxf twin-peg cmntd fem md pma; item# 161469; lot# 805270.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2024-00050 and 3002806535-2024-00051.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that three years and two months post initial implantation, the patient underwent a revision surgery due to unknown reasons.Due diligence is in progress for this complaint; to date no additional information or product has been received.

• Brand Name: OXF UNI TIB TRAY SZA RM
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18694524
• MDR Text Key: 335244626
• Report Number: 3002806535-2024-00052
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 154719
• Device Lot Number: 797490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2020
• 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): Required Intervention; Hospitalization
• Patient Sex: Female