FDA Adverse Event
Other
Summary report: N
FMP HIP
MDR report key: 2214070
·
Received August 2, 2011
Report
- Report Number
- 1644408-2011-00442
- Event Type
- Other
- Date Received
- August 2, 2011
- Date of Event
- July 26, 2011
- Report Date
- July 26, 2011
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- LPH
- PMA / PMN Number
- K003250
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY - THE PATIENT WAS EXPERIENCING PAIN ON THE ACETABULAR SIDE OF THE PROSTHESIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FMP HIP | COCR HEAD NEUTRAL | LPH | ENCORE MEDICAL, L.P. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention | 432-28-207, LOT N/A| 430-03-052, LOT N/A |