FDA Adverse Event
Injury
Summary report: N
DEPUY PINNACLE ACETABULAR CUP SYSTEM
MDR report key: 2932866
·
Received January 25, 2013
Report
- Report Number
- MW5028752
- Event Type
- Injury
- Date Received
- January 25, 2013
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- LPH
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- LA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
I HAD A TOTAL HIP REPLACEMENT ON (B)(6) 2010. I REC'D THE DEPUY TOTAL HIP PINNACLE ACETABULAR CUP, SZ MM50, ALTRX 10 DEGREES, 32 X 50 ID X OD +4, AML 6" SMALL STATURE. PRIOR TO SURGERY, I HAD LEFT ANTERIOR GROIN PAIN WHICH RADIATED INTO MY ANTERIOR THIGH. I AM UNABLE TO WORK AT MY JOB AS A REGISTERED NURSE, CANNOT WALK FOR EXTENDED PERIODS OF TIME, CLIMB STAIRS OR LADDERS, LIFTING, CANNOT SIT FOR AN EXTENDED PERIOD OF TIME. I AM LIMITED IN WHERE I GO AND WHEN, I SELDOM LEAVE HOME WITH OUT SOMEONE WITH ME AND I LIMIT WHERE I GO FOR FEAR FALLING. MY LEFT LEG IS WEAK AND I AM PRONE TO FALLING. REASON FOR USE: LEFT HIP OSTEOARTHROSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 36322 | DEPUY PINNACLE ACETABULAR CUP SYSTEM | METAL-ON-METAL HIP IMPLANT | LPH | DEPUY ORTHOPAEDICS, INC. | 1217-22-050 | EH6HS1000 | |
| 36323 | DEPUY ALTRX | ACETABULAR LINER | JDI | DEPUY ORTHOPAEDICS, INC. | |||
| 36324 | DEPUY AML 6" SMALL STATURE 10 DEGREE, 32 X 50 ID X OD +4 | HIP IMPLANT | JDI | DEPUY ORTHOPAEDICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |