MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TWIN-PEG FEMORAL MD; OXFORD CEMENTED FEMORALS

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Synovitis (2094)

Event Date 01/22/2024

Event Type  Injury  

Event Description

It was reported that a patient had an initial left medial unicondylar knee arthroplasty.Subsequently, the patient reported persistent pain and first presented with microinstability within the joint.Nearly 7 years postop, the patient presented to the emergency department where a fractured femoral component was identified on x-ray.The patient underwent a revision surgery; during which, the fractured femoral component was confirmed.All initial implants were replaced with total knee arthroplasty components without complication.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).D10 - medical devices: oxf uni tib tray sz d lm; item# 154724; lot# 3945434.Oxf anat brg lt md size 3 pma; item# 159547; lot# 3923497.Palacos cement; item# 66017747; lot# 86574616.G2 - foreign: germany.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: OXFORD UNI TWIN-PEG FEMORAL MD
• Type of Device: OXFORD CEMENTED FEMORALS
• 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: 18674291
• MDR Text Key: 334949144
• Report Number: 3002806535-2024-00046
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 166942
• Device Lot Number: J3953454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/07/2017
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 109 KG