MAUDE Adverse Event Report: BIOMET UK LTD. OX UN PH3 TRL BEAR MED SIZE 45 .; PROSTHESIS, KNEE

Model Number N/A

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 01/12/2016

Event Type  malfunction  

Manufacturer Narrative

The user facility is outside of the united states.The necessary manufacturing history was not provided for review.Current information is insufficient to permit a conclusion as to the cause of the event.The device is reportedly available for evaluation; however, it has not been received by biomet 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 that the patient underwent a partial knee arthroplasty on (b)(6) 2016.During the procedure, the threads on the trial bearing that link the trial bearing with the handle were stripped.There was another device available to complete the procedure without delay or patient injury.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation of returned device found no evidence of product nonconformance.During the evaluation, wear and markings were noted on the device.Root cause of the event was most likely due to the instrument being used beyond its useful life, as it was determined to be in use for over 16 years.There are warnings in the package insert that this type of an event can occur.Under warning, number 6 states, "intra-operative fracture or breaking of instruments has been reported.Surgical instruments are subject to wear with normal usage.Instruments, which have experienced extensive use or excessive force, are susceptible to fracture," and, "biomet recommends that all instruments be regularly inspected for wear and disfigurement.".

• Brand Name: OX UN PH3 TRL BEAR MED SIZE 45 .
• 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: 5477774
• MDR Text Key: 39615938
• Report Number: 3002806535-2016-00092
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Initial,Followup,Followup
• Report Date: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 32-420378
• Device Lot Number: 129793
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2016
• Initial Date FDA Received: 03/03/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/26/2016; 07/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1