FDA Adverse Event
Injury
Summary report: N
VHS VARIABLE ANGLE PLATE
MDR report key: 218419
·
Received April 8, 1999
Report
- Report Number
- 1825034-1999-00045
- Event Type
- Injury
- Date Received
- April 8, 1999
- Date of Event
- March 8, 1999
- Report Date
- April 7, 1999
- Manufacturer
- BIOMET, INC.
- Product Code
- HRS
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
FOLLOWING INSERTION ON 10/27/98, COMPRESSION HIP SCREW WAS REVISED TO TOTAL HIP ARTHROPLASTY ON 03/08/99, DUE TO A FAILED INTERTROCHANTERIC FRACTURE AND THE COLLAPSE OF THE PLATE COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VHS VARIABLE ANGLE PLATE Implant | FIXATION, TRAUMA, COMP. | HRS | BIOMET, INC. | NA | 532710 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |