MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI CMNTLS TIB SZ C RM; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 02/22/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D-10: oxford ph3 cementless fem sz m, item# 154926, lot# 7349086; oxf anat brg rt md size 6 pma, item# 159578, lot# 7052368.G2 ¿ foreign ¿ netherlands.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2024 - 00092, 3002806535 - 2024 - 00094.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 from a clinical study that a patient had an initial right medial knee unicondylar arthroplasty approximately one year ago.A month ago the patient was converted to a total knee arthroplasty due to persistent pain and malalignment.Due diligence is in progress for this complaint; to date no additional information or product has been received.

• Brand Name: OXF UNI CMNTLS TIB SZ C RM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL
• 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: 18920193
• MDR Text Key: 337847323
• Report Number: 3002806535-2024-00093
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 00887868354748
• UDI-Public: (01)00887868354748(17)320705(10)7246480
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 166575
• Device Lot Number: 7246480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 105 KG