FDA Adverse Event
Injury
Summary report: N
PINNACLE CUP
MDR report key: 2132691
·
Received June 10, 2011
Report
- Report Number
- MW5021004
- Event Type
- Injury
- Date Received
- June 10, 2011
- Date of Event
- June 2, 2011
- Report Date
- June 10, 2011
- Manufacturer
- DEPUY
- Product Code
- KWA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
REMOVAL OF A DEPUY PINNACLE CUP, LINER, AND SUMMIT STEM 3 YEARS AFTER IMPLANTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PINNACLE CUP | CUP | KWA | DEPUY | |||
| 2 | PINNACLE LINER | LINER | KWA | DEPUY | |||
| 3 | PINNACLE SUMMIT STEM | STEM | LPH | DEPUY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization |