FDA Adverse Event
Injury
Summary report: N
EXETER V40 STEM 44MM NO 1
MDR report key: 1013578
·
Received March 13, 2008
Report
- Report Number
- 9610669-2008-00005
- Event Type
- Injury
- Date Received
- March 13, 2008
- Date of Event
- January 21, 2008
- Report Date
- February 15, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS CAEN
- Product Code
- KWY
- PMA / PMN Number
- K011623
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD BEEN EXPERIENCING PAIN IN THEIR HIP. ON ASSESSMENT, THE STEM WAS FOUND TO BE FRACTURED AND JUST BELOW THE FRACTURE SITE THERE WAS A LARGE AMOUNT OF CEMENT PRESENT. THE STEM WAS REVISED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXETER V40 STEM 44MM NO 1 | IMPLANT | KWY | STRYKER ORTHOPAEDICS CAEN | NA | GC974499 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |