FDA Adverse Event
Injury
Summary report: N
DEPUY PINNACLE - SIZE 7 HIGH OFFSET
MDR report key: 2348570
·
Received November 21, 2011
Report
- Report Number
- MW5023185
- Event Type
- Injury
- Date Received
- November 21, 2011
- Date of Event
- November 1, 2009
- Report Date
- November 15, 2011
- Manufacturer
- DEPUY ORTHO. INC.
- Product Code
- LPH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
(B)(6), 2009, I HAD A TOTAL HIP REPLACEMENT OF MY LEFT/SIDE/HIP - IT WAS A DEPUY PINNACLE MODEL. AFTER A FEW MONTHS THE PAIN BECAME SO INTENSE, IT AFFECTED SLEEP, WALKING, MOST MOVEMENTS OF MY BODY - IN (B)(6) 2010, I LEARNED OF HIP-RECALLS BY DEPUY. MY SURGEON DID ANOTHER REPLACEMENT (B)(6) 2011. NOW I'M HAVING MORE PAIN PROBLEMS THAN EVER. I REPORTED THIS TO THE DEPUY CORP. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEPUY PINNACLE - SIZE 7 HIGH OFFSET | TOTAL HIP REPLACEMENT | LPH | DEPUY ORTHO. INC. | |||
| 2 | TRI LOCK SYSTEM A56-3 HOLE PINNACLE CUP | TOTAL HIP REPLACEMENT | KWA | DEPUY ORTHO. INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other| R| S |