FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) XM STEM
MDR report key: 6000149
·
Received October 5, 2016
Report
- Report Number
- 3010536692-2016-01247
- Event Type
- Injury
- Date Received
- October 5, 2016
- Report Date
- September 26, 2016
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- KWA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
Description of Event or Problem · 1
ALLEGEDLY , PER PAPER BY SOMERS ET AL., "HIGH SERUM ION LEVELS IN CONSERVE PLUS BIG FEMORAL HEAD CEMENTED TOTAL HIP ARTHROPLASTY.", HIP INT. 2016 SEP: ALLEGEDLY HIP REVISED FOR A LATE PERIPROSTHETIC FEMORAL BONE FRACTURE, 18 MONTHS POST OPERATION. THE FEMORAL STEM AND FEMORAL HEAD WERE REVISED, WHEREAS THE ACETABULAR SHELL WAS RETAINED AND CONVERTED TO A DUAL MOBILITY THA. NO FURTHER DETAILS OF THE PATIENT OR IMPLANTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 651876 | PROFEMUR(R) XM STEM | HIP COMPONENT | KWA | MICROPORT ORTHOPEDICS INC. | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |