MAUDE Adverse Event Report: BIOMET INC. BIOMET HIP IMPLANT METAL HIP IMPLANT WITH RING LOCK

Lot Number 847500

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 02/01/2011

Event Type  Injury  

Event Description

On (b)(6) 2011, i had a left complete hip implant then on (b)(6) 2011, it dislocated. I was in the hospital for 3 days. Now it is slipping, popping, burning, and sore. My doctor placed me back into therapy again. The implant should have never dislocated or popped and sliped. It is very sore and the public needs to know about this hip implant. There's three serial numbers and my hip implant has a plastic liner and a ring lock on it. I am back in therapy again for the third time.

• Brand Name: BIOMET HIP IMPLANT
• Type of Device: METAL HIP IMPLANT WITH RING LOCK
• Manufacturer (Section D): BIOMET INC.
• MDR Report Key: 2554592
• MDR Text Key: 2687484
• Report Number: MW5025203
• Device Sequence Number: 1
• Product Code: KWA

Combination Product (Y/N)

• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 04/26/2012
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: LAY USER/PATIENT
• Device LOT Number: 847500
• Was Device Available For Evaluation?: No
• Was the Report Sent to FDA?: No
• Is this a Reprocessed and Reused Single-Use Device?: No

Patient TREATMENT DATA

Date Received: 04/26/2012 Patient Sequence Number: 1