MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD KNEE; PROSTHESIS, KNEE

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 02/25/2009

Event Type  Injury  

Event Description

It was reported that patient underwent partial knee arthroplasty on an unknown date in 2009.Approximately six months later, a revision procedure was performed due to patient allegations of disassociation of the bearing.Subsequently, a second revision procedure was performed on an unknown date due to patient allegations of disassociation.All components were removed and replaced with a total knee system.This report is based on allegations set forth in patients complaint, and the allegations contained therein are unverified.

Event Description

It was reported patient underwent a left partial knee arthroplasty in 2003 and a right partial knee arthroplasty on (b)(6) 2008.Subsequently, patient underwent a revision procedure on the right knee on (b)(6) 2009 due to dislocation.Operative report noted joint effusion and fluid during the revision procedure.The tibial bearing was removed and replaced.Patient underwent another revision procedure on the right knee on (b)(6) 2012 due to disassociation.All components were removed and a total knee system was implanted.This report is based on allegations set forth in patients complaint, and the allegations contained therein are unverified.

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.This report is based on allegations set forth in patients complaint, and the allegations contained therein are unverified.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

• Brand Name: UNKNOWN OXFORD KNEE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estate; bridgend, south wales CF31 3XA
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3736282
• MDR Text Key: 4219986
• Report Number: 0001825034-2014-02531
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 05/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 57 YR