FDA Adverse Event
Injury
Summary report: N
APR HOODED ENHANCED INSERT 28MM/59MM
MDR report key: 107412
·
Received July 24, 1997
Report
- Report Number
- 2935620-1997-00020
- Event Type
- Injury
- Date Received
- July 24, 1997
- Date of Event
- June 26, 1995
- Report Date
- July 24, 1997
- Manufacturer
- SULZER ORTHOPEDICS, INC.
- Product Code
- KWB
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
NOTICE OF REVISION SURGERY FROM RISK MANAGEMENT-PATIENT. ON 05/20/1996 PT REPORTED HE FELT LIKE HIS HIP POPPED WHILE WASHING HIS CAR. ON 06/24/96 PT REPORTED WHILE HE "WAS DOWN AT THE RIVER YESTERDAY" AND FELT AS IF "SOMETHING WENT OUT OF PLACE," AND THEN IT WENT BACK IN, BUT FOLLOWING THAT THERE WAS A GRINDING TYPE SENSATION IN THE HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APR HOODED ENHANCED INSERT 28MM/59MM Implant | HIP INSERT PROSTHESIS | KWB | SULZER ORTHOPEDICS, INC. | NA | 31442 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Hospitalization| R | 1. 4311-00-059 SCREWLESS SHELL| 3. 7416-02-165 RIGHT HIP STEM| 2. 7210-28-400 COCR HEAD |