MAUDE Adverse Event Report: BIOMET UK LTD. RECAP FEM HD COCR CEMENTED 50MM; RECAP FEMORAL HEAD

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); Toxicity (2333); Deformity/ Disfigurement (2360)

Event Date 06/13/2013

Event Type  Injury  

Event Description

It was reported by the patient's legal representative that the patient underwent a hip resurfacing procedure on the right hip on (b)(6) 2005 and subsequently was revised on (b)(6) 2013 due to pain, elevated metal ion levels, fluid collection and a difference of leg lengths.This complaint is based on allegations set forth in patient's notice and the allegations therein are unverified.

Manufacturer Narrative

The user facility is outside of the united states.No medwatch report was received.No product was returned.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.Initial reporter - unknown.This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.This is 2 of 2 mdr reports submitted for the same event.Also see: 3002806535-2014-00011.

• Brand Name: RECAP FEM HD COCR CEMENTED 50MM
• Type of Device: RECAP FEMORAL HEAD
• 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: sian rogers ; waterton industrial estates; bridgend CF31 -3XA ; UK CF31 3XA ; 0441656655
• MDR Report Key: 3568376
• MDR Text Key: 4072283
• Report Number: 3002806535-2014-00012
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK021799
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 12/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 157250
• Device Lot Number: 843436
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2004
• 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
• Patient Age: 66 YR