FDA Adverse Event
Injury
Summary report: N
BIOPRO
MDR report key: 316535
·
Received February 16, 2001
Report
- Report Number
- 1833506-2001-00001
- Event Type
- Injury
- Date Received
- February 16, 2001
- Date of Event
- June 27, 2000
- Report Date
- February 14, 2001
- Manufacturer
- BIOPRO, INC.
- Product Code
- JDI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
LETTER RECEIVED IN 1-2001 STATED THAT PT WAS WALKING, TOOK A STEP AND WENT DOWN. HIP STEM FRACTURED AT THE BALLOON AND TRUNNION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 6373 | BIOPRO | FEMORAL HEAD, HIP STEM | JDI | BIOPRO, INC. | * | 91-0257 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Hospitalization| R |