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

Model Number PINNACLE SECTOR 11

Device Problems Screw (568); Bent (1059); Failure to Osseointegrate (1863); Device Dislodged or Dislocated (2923)

Patient Problem Inadequate Osseointegration (2646)

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.

• Brand Name: DEPUY PINNACLE HIP IMPLANT WITH POLY LINER
• Type of Device: HIP REPLACEMENT PARTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS; po box 988; warsaw IN 46581
• MDR Report Key: 2622828
• MDR Text Key: 2727358
• Report Number: MW5025850
• Device Sequence Number: 1
• Product Code: LPH

Combination Product (Y/N)

• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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 Received: 06/07/2012
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: LAY USER/PATIENT
• Device EXPIRATION Date: 10/01/2020
• Device MODEL Number: PINNACLE SECTOR 11
• Device Catalogue Number: 1217-22-058
• 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: