MAUDE Adverse Event Report: BIOMET UK LTD. OXF PKS ANAT MEN BEARING UHMWPE LT SML SZ 4; PROSTHESIS, KNEE

Model Number N/A

Device Problems Material Separation (1562); Metal Shedding Debris (1804)

Patient Problems Fall (1848); Unspecified Infection (1930)

Event Date 08/04/2015

Event Type  Injury  

Manufacturer Narrative

The 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.The following sections could not be completed with the limited information provided: brand name, device info, date implanted : approximately 4 years ago, pma/510(k) number, and manufacture date.

Event Description

It was reported that patient underwent a unicompartmental knee arthroplasty approximately 4 years ago.Subsequently, a revision procedure was performed on (b)(6) 2015 due infection, metallosis in the joint capsule and anterior disassociation of the polyethylene bearing after patient fall.During the procedure, the polyethylene bearing was replaced.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.Dimensional evaluation could not be completed as dimensional integrity may have been breached during decontamination.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 6 states, "material sensitivity reactions." number 8 states, "'early or late postoperative infection and allergic reaction." number 16 states, "wear and/or deformation of articulating surfaces.".

• Brand Name: OXF PKS ANAT MEN BEARING UHMWPE LT SML SZ 4
• 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: 5047164
• MDR Text Key: 24767723
• Report Number: 3002806535-2015-00334
• 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: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2014
• Device Model Number: N/A
• Device Catalogue Number: 159541
• Device Lot Number: 1827911
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2009
• 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