FDA Adverse Event
Injury
Summary report: N
UNKNOWN OSTEONIC #8
MDR report key: 2125163
·
Received June 2, 2011
Report
- Report Number
- 2249697-2011-00807
- Event Type
- Injury
- Date Received
- June 2, 2011
- Date of Event
- February 24, 2009
- Report Date
- May 9, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "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, 2009-2011, 2 YEARS. DIAGNOSIS OR REASON FOR USE: LEFT FEMORAL NECK FRACTURE, #8 OSTEONIC AND THERAPY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN OSTEONIC #8 | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other| R |