MAUDE Adverse Event Report: BIOMET OXFORD; OXFORD UNOCOMPARTMENTAL KNEE FEMORAL

Device Problems Deformation Due to Compressive Stress (2889); Device Operates Differently Than Expected (2913)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 08/18/2016

Event Type  malfunction  

Event Description

Right knee unicompartmental biomet oxford, constant pain.Tried anti-inflammatory meds, pain meds.Knee is warm to the touch, sometimes "buckles", almost falling.Pain persists and continues to this day ((b)(6) 2017).Suggested by orthopedic surgeon that i need revision surgery.

• Brand Name: OXFORD
• Type of Device: OXFORD UNOCOMPARTMENTAL KNEE FEMORAL
• Manufacturer (Section D): BIOMET
• MDR Report Key: 7137456
• MDR Text Key: 95506657
• Report Number: MW5074139
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BISOPROLOL FOR HBP; CANE NEEDED FOR STABILITY WHEN WALKING.
• Patient Age: 65 YR
• Patient Weight: 83