FDA Adverse Event
Other
Summary report: N
FMP HIP
MDR report key: 2092936
·
Received May 10, 2011
Report
- Report Number
- 1644408-2011-00268
- Event Type
- Other
- Date Received
- May 10, 2011
- Date of Event
- May 2, 2011
- Report Date
- May 2, 2011
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- LPH
- PMA / PMN Number
- K974093
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE MAN HOLE COVER PUSHED THROUGH THE CUP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FMP HIP | HEMI W/HOLES SHELL | LPH | ENCORE MEDICAL, L.P. | 288C1003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |