FDA Adverse Event
Injury
Summary report: N
APR HOODED PROTRUSIO ENHANCED INSERT 26MM/47MM
MDR report key: 49956
·
Received November 20, 1996
Report
- Report Number
- 2935620-1996-00010
- Event Type
- Injury
- Date Received
- November 20, 1996
- Date of Event
- August 1, 1996
- Report Date
- November 19, 1996
- Manufacturer
- INTERMEDICS ORTHOPEDICS, 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
REVISION SURGERY-HEAD DISASSOCIATED FROM LINER. UNDETERMINED WHAT HAPPENED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APR HOODED PROTRUSIO ENHANCED INSERT 26MM/47MM Implant | HIP IMPLANT PROSTHESIS | KWB | INTERMEDICS ORTHOPEDICS, INC. | NA | 34460 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Required Intervention |