FDA Adverse Event
Injury
Summary report: N
OSTEONIC
MDR report key: 1994984
·
Received February 11, 2011
Report
- Report Number
- MW5019421
- Event Type
- Injury
- Date Received
- February 11, 2011
- Date of Event
- February 24, 2009
- Report Date
- February 11, 2011
- Manufacturer
- STRYKER
- Product Code
- HSB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- AL, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I HAVE NOT HAD ONE PAIN FREE DAY SINCE MY SURGERY. IT HAS MOVED ALL THE WAY DOWN MY LEFT LEG. I AM NOW GOING TO A PAIN CLINIC BECAUSE IT IS CHRONIC PAIN. I WALK WITH A BAD LIMP. I CAN AT TIMES HEAR MY HIP POPPING AND ALSO FEEL IT. DATES OF USE: (B)(6) 2009 - (B)(6) 2011, 2 YEARS. DIAGNOSIS OR REASON FOR USE: LEFT FEMORAL NECK FRACTURE. #8 OSTEONIC AND THERAPY (B)(6) 2009. ALSO (B)(6) 2009.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OSTEONIC | #8 OSTEONIC | HSB | STRYKER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Hospitalization| O| R| S |