FDA Adverse Event
Other
Summary report: N
CUP, AL-AL FLARED RIM
MDR report key: 983726
·
Received January 18, 2008
Report
- Report Number
- 1644408-2008-00014
- Event Type
- Other
- Date Received
- January 18, 2008
- Date of Event
- December 20, 2007
- Report Date
- January 18, 2008
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- KWB
- 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 DISLOCATION. REPLACED CUP, LINER, AND HEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CUP, AL-AL FLARED RIM | AL-AL SHELLS | KWB | ENCORE MEDICAL, L.P. | 53812714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention | 498-28-048 LOT #53862343| 400-01-290 LOT #247232K1 |