FDA Adverse Event
Other
Summary report: N
KERAMOS HIP
MDR report key: 1880581
·
Received October 20, 2010
Report
- Report Number
- 1644408-2010-00562
- Event Type
- Other
- Date Received
- October 20, 2010
- Date of Event
- October 12, 2010
- Report Date
- October 12, 2010
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- LZO
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY - PELVIC FRACTURE, REMOVED SHELL AND REPLACED WITH CERAMIC SLEEVE AND HEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KERAMOS HIP | FLARED RIM SHELL CERAMIC-CERAMIC | LZO | ENCORE MEDICAL, L.P. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |