FDA Adverse Event
Injury
Summary report: N
ITST INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION LAG SCREW
MDR report key: 413904
·
Received August 30, 2002
Report
- Report Number
- 1822565-2002-00103
- Event Type
- Injury
- Date Received
- August 30, 2002
- Date of Event
- June 7, 2002
- Report Date
- July 31, 2002
- Manufacturer
- ZIMMER, INC.
- Product Code
- NDE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ANTI-ROTATION SCREW AND LAG SCREW CUT OUT OF FEMORAL HEAD/NECK. PATIENT HAD A HISTORY OF AVASCULAR NECROSIS. DEVICES REMOVED AND REVISED TO A TOTAL HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITST INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION LAG SCREW | LAG SCREW | NDE | ZIMMER, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Hospitalization| R |