MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PKS COCR SIZE C RM STD; PROSTHESIS, KNEE

Model Number N/A

Device Problem Off-Label Use (1494)

Patient Problem No Code Available (3191)

Event Date 01/17/2014

Event Type  Injury  

Event Description

It has been reported by the hospital that during a primary knee surgery on (b)(6) 2014, a surgeon implanted a cemented oxford tibial into a patient thinking it was an uncemented tibial.The patient was called back to the hospital the next day for a revision surgery to implant the correct item.

Manufacturer Narrative

The user facility is outside of the united states.No medwatch report was received.No product was returned.Current information is insufficient to permit a conclusion as to the cause of the event.No further complications have been reported.

• Brand Name: OXFORD PKS COCR SIZE C RM STD
• 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: sian rogers ; waterton industrial estates; bridgend CF31 -3XA ; UK CF31 3XA ; 0441656655
• MDR Report Key: 3633369
• MDR Text Key: 3984564
• Report Number: 3002806535-2014-00052
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 154723
• Device Lot Number: 2524292
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2011
• 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