FDA Adverse Event
Injury
Summary report: N
UNKNOWN_RECONSTRUCTIVE_PRODUCT
MDR report key: 3870867
·
Received June 12, 2014
Report
- Report Number
- 0002249697-2014-02248
- Event Type
- Injury
- Date Received
- June 12, 2014
- Date of Event
- February 18, 2011
- Report Date
- May 21, 2014
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- JDI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE CATALOG NUMBER AND LOT CODE OF THE FEMORAL COMPONENT WERE NOT PROVIDED. AN UNKNOWN STEM WAS ADDED BASED UPON THE DETAILS OF THE EVENT DESCRIPTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND THE CONTACT INDICATED THAT NO FURTHER INFORMATION WOULD BE AVAILABLE FOR EVALUATION OF THE REPORTED EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A RIGHT TOTAL HIP ARTHROPLASTY REVISION DUE TO FEMORAL COMPONENT LOOSENING SECONDARY TO PERIPROSTHETIC FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 347379 | UNKNOWN_RECONSTRUCTIVE_PRODUCT | IMPLANT | JDI | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Hospitalization| R |