EXETER V40 STEM 44MM NO 0
Report
- Report Number
- 0002249697-2013-01042
- Event Type
- Injury
- Date Received
- March 20, 2013
- Date of Event
- February 24, 2013
- Report Date
- February 25, 2013
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- K011623
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- PHYSICIAN
Narratives
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
DATE OF BIRTH UPDATED. CORRECTED DATA: IMPLANT DATE. AN EVENT REGARDING STEM FRACTURE INVOLVING AN EXETER DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICES ASSOCIATED WITH THE EVENT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE LOT WAS UNKNOWN. THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE OF THIS EXETER STEM FRACTURE WAS A RESULT OF CYCLIC LOADING AT THE JUNCTION OF THE PROXIMAL LOOSE STEM AND THE WELL-FIXED DISTAL STEM RESULTED IN INEVITABLE FATIGUE FRACTURE OF THE STEM. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.
REVISION OF AN EXETER 44 #0 STEM. THE STEM HAD BEEN IN AROUND 5 YEARS AND HAD A COMPLETE TRANSVERSE FRACTURE MID EXETER STEM. FEMUR WAS INTACT.
REVISION OF AN EXETER 44 #0 STEM. THE STEM HAD BEEN IN AROUND 5 YEARS AND HAD A COMPLETE TRANSVERSE FRACTURE MID EXETER STEM. FEMUR WAS INTACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116654 | EXETER V40 STEM 44MM NO 0 | IMPLANT | JDI | STRYKER ORTHOPAEDICS-MAHWAH | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Hospitalization| O| R |