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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS DEPUY PINNACLE HIP IMPLANT WITH POLY LINER HIP REPLACEMENT PARTS

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DEPUY ORTHOPAEDICS DEPUY PINNACLE HIP IMPLANT WITH POLY LINER HIP REPLACEMENT PARTS Back to Search Results
Model Number PINNACLE SECTOR 11
Event Date 05/23/2012
Event Type  Injury  
Event Description

Depuy pinnacle hip implant with poly liner. Original implant which is the one i am describing placed in body (b)(6) 2010, had to be replaced as a result of the failure of the acetabular cup, pinnacle ii acetabularcu sz mm 58 with pinnacle altrx +4 10 degree id x od 35 x 58 liner. After 2 years of constant pain and complaints, surgeon found the acetabular cup had no bone growth, had dropped almost 1/2" and the pinnacle cancellous bone screw 6. 6 mm x 30 mm had bent 1/4". The other part of the depuy sys seemed to hold up; that being the summit tapered stem with porocoat yet, the articuleze metal on metal femoral head was replaced. It is important to note that this depuy pinnacle sys did have the poly liner and still the cup pulled away from the hips and the holding screw bent. All replaced parts are being held by the hosp for eventual examination. I am listing below the parts that failed as examined by the hosp and surgeon. Failure resulted from no bone growth at all to the cup. Excellent bone growth to the femur with the summit stem with porocoat. (b)(6) 2012, all parts replaced in the hip revision surgery for failure as follows: tests and results confirmed by hosp lab. Still holding parts.

 
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Brand NameDEPUY PINNACLE HIP IMPLANT WITH POLY LINER
Type of DeviceHIP REPLACEMENT PARTS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS
po box 988
warsaw IN 46581
MDR Report Key2622828
Report NumberMW5025850
Device Sequence Number1
Product CodeLPH
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 06/07/2012
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received06/07/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberPINNACLE SECTOR 11
Device Catalogue Number1217-22-058
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 06/07/2012 Patient Sequence Number: 1
Treatment
PINNACLE SECTOR ACETABULAR CUP DEPUY:
REFERENCE (B)(4), LOT D91H81
APEX HOLE ELIMINATOR PS:
PINNACLE ALTRX +4 10 DEGREE LINER:
REFERENCE (B)(4), LOT 421812
REFERENCE (B)(4), LOT EG2EP1000
36MM - 2 12/14 TAPER
REFERENCE (B)(4), LOT D4NGC1000
PINNACLE CANCELLOUS BONE SCREW 6.5MMX30MM:
ARTICUL/EZE METAL ON METAL FEMORAL HEAD:
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