FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) MODULAR FEMORAL NECK
MDR report key: 6425541
·
Received March 22, 2017
Report
- Report Number
- 3010536692-2017-00408
- Event Type
- Injury
- Date Received
- March 22, 2017
- Report Date
- March 6, 2017
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- LWJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT WILL BE UPDATED ONCE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
Description of Event or Problem · 1
PER MOHAMMED, R. AND P. CNUDDE, "SEVERE METALLOSIS OWING TO INTRAPROSTHETIC DISLOCATION IN A FAILED DUAL-MOBILITY CUP PRIMARY TOTAL HIP ARTHROPLASTY." J ARTHROPLASTY, 2012. 27(3): P. 493.E1-3: ALLEGEDLY A (B)(6) MALE WITH A CONTACT E FEMORAL STEM, PROFEMUR TI MODULAR NECK, 28MM COCR HEAD, AND A 52MM DUAL MOBILITY CUP OF ANOTHER MANUFACTURER ((B)(4)) UNDERWENT A REVISION DUE TO A LARGE CYST WITHIN THE ILIOPSOAS MUSCLE AND METALLOSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 206486 | PROFEMUR(R) MODULAR FEMORAL NECK | HIP COMPONENT | LWJ | MICROPORT ORTHOPEDICS INC. | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |