FDA Adverse Event
Summary report: N
*
MDR report key: 976174
·
Received December 19, 2007
Report
- Report Number
- 976174
- Date Received
- December 19, 2007
- Date of Event
- September 19, 2007
- Report Date
- December 19, 2007
- Manufacturer
- SMITH AND NEPHEW, INC.
- Product Code
- NDF
- Report Source
- User Facility report
- Reporter Location
- TN, US
Narratives
Description of Event or Problem · 1
PATIENT HAD AN OPEN REDUCTION INTERNAL FIXATION WITH RICHARDS HIP SCREW. AT FOLLOW-UP VISIT 2 WEEKS LATER, INCREASED PAIN. X-RAYS REVEALED LAG SCREW HAD CUT THROUGH THE FEMORAL HEAD. RETURNED TO SURGERY ONE MONTH FROM ORIGINAL SURGERY FOR REVISION OF INTERTROCHANTERIC HIP FRACTURE TO CEMENTED REVISION FEMORAL STEM WITH BIPOLAR HEAD WITH REMOVAL OF RICHARDS HIP SCREW AND SIDE PLATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | HARDWARE, ORTHOPEDIC, HIP PLATE | NDF | SMITH AND NEPHEW, INC. | * | 05BT87224 | |
| 2 | * | HARDWARE, ORTHOPEDIC, HIP SCREW LAG | NDJ | SMITH AND NEPHEW, INC. | * | 04KT8422 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | NO OTHER THERAPIES| NO OTHER THERAPIES |