FDA Adverse Event
Other
Summary report: N
CONSENSUS ACETABULAR SHELL, SZ.56MM
MDR report key: 200016
·
Received November 25, 1998
Report
- Report Number
- 2952369-1998-00005
- Event Type
- Other
- Date Received
- November 25, 1998
- Date of Event
- October 1, 1998
- Report Date
- November 1, 1998
- Manufacturer
- HAYES MEDICAL, INC.
- Product Code
- KWB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A CONSENSUS ACETABULAR SHELL, NO HOLE, POROUS TI, SZ. 56MM WAS IMPLANTED BY DR. ON 09/22/98. APPROX ONE WEEK FOLLOWING THE INITIL SURGERY THE SHELL DISLOCATED FROM THE ACETABULUM. THIS NECESSITATED A REVISION SURGERY TO REPLACE THE COMPONENT. THE REVISION SURGERY WAS PERFORMED BY DR. ON 10/01/98. THE DISLOCATED COMPONENT WAS REPLACED WITH A CONSENSUS ACETABULAR SHELL, POROUS TI, SIZE 58MM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSENSUS ACETABULAR SHELL, SZ.56MM Implant | 888.3358 | KWB | HAYES MEDICAL, INC. | 1704-0-0056 | 100370 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization| O| R | 1005-0-2856, ACETABULAR INSERT |