FDA Adverse Event
Injury
Summary report: N
SX28MM/57MM HOD INS INTER-OP
MDR report key: 280369
·
Received June 2, 2000
Report
- Report Number
- 2935620-2000-00014
- Event Type
- Injury
- Date Received
- June 2, 2000
- Date of Event
- May 4, 2000
- Report Date
- May 4, 2000
- Manufacturer
- SULZER ORTHOPEDICS, INC.
- Product Code
- LPH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED: A REVISION HIP SURGERY WAS PERFORMED DUE TO DISLOCATIONS BOTH ANTERIORLY AND POSTERIORLY. DISLOCATION MAY BE DUE TO THE POSITION OF THE CUP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SX28MM/57MM HOD INS INTER-OP | HIP PROSTHESIS | LPH | SULZER ORTHOPEDICS, INC. | NI | 1346375 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Hospitalization| R | SZ 28X57MM (LOT#1330312)(2000).| 4360-00-57 INTER-OP HEMISPHERICAL SHELL, |