FDA Adverse Event
Injury
Summary report: N
DEPUY PINNACLE SIZE 54 CUP
MDR report key: 1893130
·
Received November 1, 2010
Report
- Report Number
- MW5018052
- Event Type
- Injury
- Date Received
- November 1, 2010
- Date of Event
- July 6, 2010
- Report Date
- November 1, 2010
- Manufacturer
- DEPUY IS A DIVISION OF JOHNSON & JOHNSON COMPANY
- Product Code
- KWA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- ID, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
ON (B)(6) 2010, I HAD TOTAL HIP REPLACEMENT SURGERY USING DEPUY PINNACLE AND DEPUY SUMMIT DEVICES. I NEED THE ASSISTANCE OF A WALKER AND CANNOT WALK UNAIDED. I DO NOT THINK THIS IS NORMAL; I SHOULD BE COMPLETELY RECOVERED BY NOW, AND BE ABLE TO WALK. DIAGNOSIS OR REASON FOR USE: SEVERE OSTEOARTHRITIS OF RIGHT HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEPUY PINNACLE SIZE 54 CUP | MEDICAL DEVICES USED IN PERFORMING TOTAL HIP | KWA | DEPUY IS A DIVISION OF JOHNSON & JOHNSON COMPANY | |||
| 2 | DEPUY SUMMIT SIZE 5 | MEDICAL DEVICES USED IN PERFORMING TOTAL HIP | KWA | DEPUY IS A DIVISION OF JOHNSON & JOHNSON COMPANY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |