MAUDE Adverse Event Report: BIOMET UK LTD. RECAP FEM HEAD COCR CEMENTED Ø44MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Date 11/27/2013

Event Type  Injury  

Manufacturer Narrative

This user facility is outside of the united states.The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided: device info - lot number and expiration date unknown; date implanted - date unknown; manufacture date ¿ unknown.Examination of returned device found no evidence of product non-conformance.During the evaluation, evidence of fretting was noted on the taper adapter.Evidence of wear and scratches were also found on the femoral head.However, dimensional evaluation could not be completed on the head and cup as biological residue covered the device obscuring the articulating surfaces.Therefore, a conclusive root cause could not be determined.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 11 states, "wear and/or deformation of articulating surfaces." this report is number 2 of 2 mdr's filed for the same patient (reference 3002806535-2013-00294 & 3002806535-2016-00024).

Event Description

It was reported patient underwent a hip resurfacing procedure in (b)(6) 2006 and subsequently underwent a revision procedure on (b)(6) 2013 due to an unknown mechanical complication.No further information has been received.

• Brand Name: RECAP FEM HEAD COCR CEMENTED Ø44MM
• Type of Device: PROSTHESIS, HIP
• 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: 5364310
• MDR Text Key: 35812947
• Report Number: 3002806535-2016-00024
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: PK021799
• 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: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 157244
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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