FDA Adverse Event
Other
Summary report: N
KERAMOS HIP
MDR report key: 1943850
·
Received December 22, 2010
Report
- Report Number
- 1644408-2010-00688
- Event Type
- Other
- Date Received
- December 22, 2010
- Date of Event
- December 13, 2010
- Report Date
- December 13, 2010
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- LPH
- PMA / PMN Number
- K955563
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY - DUE TO SQUEAKING. THE DR REMOVED A WELL FIXED POROUS SHELL AND PUT IT IN A ZIMMER SHELL AND OUT 10.5 SLEEVE WITH A 36 MM METAL HEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KERAMOS HIP | CERAMIC HEAD | LPH | ENCORE MEDICAL, L.P. | 548731 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention | (B)(4), LOT 548731| (B)(4), LOT 511861 |