FDA Adverse Event
Injury
Summary report: N
M/H MODULAR CALCAR STEM
MDR report key: 173308
·
Received June 19, 1998
Report
- Report Number
- 1825034-1998-00055
- Event Type
- Injury
- Date Received
- June 19, 1998
- Date of Event
- May 15, 1998
- Report Date
- June 19, 1998
- Manufacturer
- BIOMET, INC.
- Product Code
- JDI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A MEDWATCH REPORT WAS SENT FOR THIS EVENT ON 06/19/1998. AT THE TIME THE USER FACILITY HAS NOT SENT A MEDWATCH REPORT TO BIOMET. A MEDWATCH REPORT WAS RECEIVED FROM CDRH ON 07/06/1998.
Description of Event or Problem · 1
TOTAL HIP ARTHROPLASTY WAS PERFORMED ON 09/25/1996. REVISION SURGERY WAS PERFORMED ON 05/18/1998, DUE TO FRACTURE AT THE DISTAL EXTREME OF THE HIP STEM COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | M/H MODULAR CALCAR STEM Implant | PROSTHESIS, HIP, COMP. | JDI | BIOMET, INC. | NA | 047650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization| R |