FDA Adverse Event
Injury
Summary report: N
EXETER. FEMORAL STEM +2 PMMA CENTRALISERS 205MM LO
MDR report key: 1012651
·
Received March 11, 2008
Report
- Report Number
- 9610669-2008-00004
- Event Type
- Injury
- Date Received
- March 11, 2008
- Date of Event
- February 11, 2008
- Report Date
- February 13, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS CAEN
- Product Code
- KWY
- PMA / PMN Number
- K891454
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT: PATIENT HAS A SUBTROCHANTERIC FRACTURE OF BOTH STEM AND FEMUR. THE FRACTURE OF THE STEM IS ABOUT 10 CM. FROM THE DISTAL PART OF THE EXETER STEM SO, PATIENT UNDERWENT REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXETER. FEMORAL STEM +2 PMMA CENTRALISERS 205MM LO | IMPLANT | KWY | STRYKER ORTHOPAEDICS CAEN | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |