FDA Adverse Event
Other
Summary report: N
UNISYN HIP SYSTEM
MDR report key: 478452
·
Received August 13, 2003
Report
- Report Number
- 2952369-2003-00002
- Event Type
- Other
- Date Received
- August 13, 2003
- Date of Event
- July 25, 2003
- Report Date
- August 12, 2003
- Manufacturer
- HAYES MEDICAL, INC.
- Product Code
- JDI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A BROKEN UNISYN HIP SYSTEM NECK COMPONENT WAS REPORTED. IT WAS REPORTED THAT THE PATIENT ATTEMPTED TO SQUAT DOWN TO SIT ON A LOW OBJECT AND FELT THE IMPLANT SNAP. SURGICAL REVISION WAS REQUIRED TO REMOVE THE BROKEN COMPONENTS AND REPLACE WITH A NEW PROSTHESIS. DUE TO BROKEN NECK COMPONENT, THE THREADED PORTION OF THE STEM COMPONENT WAS ALSO BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNISYN HIP SYSTEM | STEM, FLUTED, STRAIGHT, 15 X 150 MM | JDI | HAYES MEDICAL, INC. | NA | 490089 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Hospitalization| R | BODY COMPONENT, LOCKING NUT. |