MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PKS MEN BEARING UHMWPE MED SZ 7; PROSTHESIS, KNEE

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 07/23/2015

Event Type  Injury  

Manufacturer Narrative

The user facility is outside of the united states.No medwatch report was received.Current information is insufficient to permit a conclusion as to the cause of the event.No further complications have been reported.Implant date - approximately 14 years ago.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.

Event Description

It was reported that patient underwent a unicompartmental knee arthroplasty approximately 14 years ago.Subsequently, a revision procedure was performed on (b)(6) 2015 due to anterior impingement.During the procedure, the femoral component and tibial bearing were replaced.

Manufacturer Narrative

Dimensional evaluation found component to be within appropriate design specification.Root cause of the event was most likely attributed to third party debris; however, a conclusive determination could not be made.

• Brand Name: OXFORD PKS MEN BEARING UHMWPE MED SZ 7
• Type of Device: PROSTHESIS, KNEE
• 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: daniel tilbury ; waterton industrial estates; bridgend CF31 -3XA ; UK CF31 3XA ; 0441656655
• MDR Report Key: 5011838
• MDR Text Key: 23382743
• Report Number: 3002806535-2015-00322
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2004
• Device Model Number: N/A
• Device Catalogue Number: 154630
• Device Lot Number: 357730
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/1999
• 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