FDA Adverse Event
Injury
Summary report: N
SULZER MEDICA
MDR report key: 316216
·
Received February 14, 2001
Report
- Report Number
- MW1021090
- Event Type
- Injury
- Date Received
- February 14, 2001
- Date of Event
- January 23, 2001
- Report Date
- February 10, 2001
- Manufacturer
- SULZER MEDICA SULZER ORTHOPEDICS, INC.
- Product Code
- KWB
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT EXPERIENCED LOOSENING OF ACETABULAR SHELL. (INITIAL SURGERY LESS THAN 2 MONTHS PREVIOUS).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5628 | SULZER MEDICA | ACETABULAR SHELL | KWB | SULZER MEDICA SULZER ORTHOPEDICS, INC. | ACETABULAR SHELL | 1436066 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |