MAUDE Adverse Event Report: BIOMET UK LTD. OXF PKS DOMED LAT MEN BRG UHMW PE MED SZ4; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problem No Code Available (3191)

Event Date 12/15/2015

Event Type  Injury  

Manufacturer Narrative

This user facility is outside of the united states.Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet in warsaw, indiana manufactures a similar device in the united states under 510k number p010014.

Event Description

It was reported that patient underwent partial knee arthroplasty on (b)(6) 2010.Subsequently, a revision procedure was performed on (b)(6) 2015 due to instability.

• Brand Name: OXF PKS DOMED LAT MEN BRG UHMW PE MED SZ4
• 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: 5355228
• MDR Text Key: 35530641
• Report Number: 3002806535-2016-00019
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2013
• Device Model Number: N/A
• Device Catalogue Number: 161695
• Device Lot Number: 1520551
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2015
• Initial Date FDA Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/04/2006
• 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