FDA Adverse Event
Malfunction
Summary report: N
FMP HIP
MDR report key: 2002290
·
Received January 26, 2011
Report
- Report Number
- 1644408-2011-00049
- Event Type
- Malfunction
- Date Received
- January 26, 2011
- Date of Event
- January 19, 2011
- Report Date
- January 19, 2011
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- LPH
- PMA / PMN Number
- K973119
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
WHILE IMPLANT BEING PLACED IN, IT WAS NOTICED SOME OF THE POROUS COATING HAD DELAMINATED OFF OF THE BACKSIDE OF THE CUP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FMP HIP | ACETABULAR SPIKED CUP | LPH | ENCORE MEDICAL, L.P. | 53874130 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR |