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U.S. Department of Health and Human Services

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

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BIOMET INC. BIOMET HIP IMPLANT METAL HIP IMPLANT WITH RING LOCK   Back to Search Results
Lot Number 847500
Event Date 02/01/2011
Event Type  Injury   Patient Outcome  Hospitalization
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.

 
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Brand NameBIOMET HIP IMPLANT
Type of DeviceMETAL HIP IMPLANT WITH RING LOCK
Manufacturer (Section F)
BIOMET INC.
Manufacturer (Section D)
BIOMET INC.
Device Event Key2584876
MDR Report Key2554592
Event Key2451323
Report NumberMW5025203
Device Sequence Number1
Product CodeKWA
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/26/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device LOT Number847500
Was Device Available For Evaluation? No
Was the Report Sent to FDA? No
Was The Report Sent To Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?

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