MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PKS TIB TRAY COCR 41X26 MM LM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Damage to Ligament(s) (1952); Rupture (2208)

Event Date 09/28/2015

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.The product identification necessary to review manufacturing history was not provided.Date implanted - year implanted 2008.Device availability - the device is reportedly available for evaluation; however, it has not been received by zimmer biomet (b)(4) to date.In the event that the device is received and evaluated, a follow-up report will be send to the fda to provide results.

Event Description

It was reported patient underwent a partial knee arthroplasty in 2008.Subsequently, a revision procedure was performed on (b)(6) 2015 due to anterior cruciate ligament (acl) rupture and lateral disease progression.The polyethylene tibial bearing, femoral component, and tibial tray were removed and replaced with total knee components.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Dimensional evaluation found component to be within appropriate design specification.

• Brand Name: OXFORD PKS TIB TRAY COCR 41X26 MM LM
• 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: 5147282
• MDR Text Key: 28141346
• Report Number: 3002806535-2015-04035
• 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
• Type of Report: Followup
• Report Date: 12/04/2015

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: 08/31/2009
• Device Model Number: N/A
• Device Catalogue Number: 154607
• Device Lot Number: S342997
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/1999
• 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