FDA Adverse Event
Injury
Summary report: N
M/H MODULAR CALCAR STEM
MDR report key: 197030
·
Received November 10, 1998
Report
- Report Number
- 1825034-1998-00088
- Event Type
- Injury
- Date Received
- November 10, 1998
- Date of Event
- October 9, 1998
- Report Date
- November 6, 1998
- Manufacturer
- BIOMET, INC.
- Product Code
- JDI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
TOTAL HIP ARTHROPLASTY WAS PERFORMED ON 03/05/1997. REVISION SURGERY WAS PERFORMED ON 10/09/1998, DUE TO HIP STEM FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | M/H MODULAR CALCAR STEM Implant | PROSTHESIS, HIP, COP. | JDI | BIOMET, INC. | NA | 427930 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |