FDA Adverse Event
Injury
Summary report: N
PROFEMUR® MODULAR FEMORAL NECK
MDR report key: 8852270
·
Received August 1, 2019
Report
- Report Number
- 3010536692-2019-00961
- Event Type
- Injury
- Date Received
- August 1, 2019
- Report Date
- February 18, 2020
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- LWJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
ALLEGEDLY, PATIENT WAS REVISED DUE TO PROSTHESIS DISLOCATION. ITEMS NOT REVISED: COTYLE "ANCA" AVEC TROUS A/REVET. HAP 52, CATALOG # PPR67252, LOT #T02118020, QTY 1. INSERT CERAM "ANCA FIT?" 28/40 50-52-54/28 AL2.O3 BIO. FORTE, CATALOG # PPR67510, LOT # T09133022, QTY 1. TIGE "ANCA FIT?" REV. HAP 1/3 PROXIMAL 11G, CATALOG # PPR67606, LOT #P0760727-2, QTY 1.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 645965 | PROFEMUR® MODULAR FEMORAL NECK | HIP COMPONENT | LWJ | MICROPORT ORTHOPEDICS INC. | PHA01204 | T11134683 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention |