FDA Adverse Event
Injury
Summary report: N
PROFEMUR MODULAR FEMORAL NECK
MDR report key: 8853681
·
Received August 1, 2019
Report
- Report Number
- 3010536692-2019-00973
- Event Type
- Injury
- Date Received
- August 1, 2019
- Report Date
- August 1, 2019
- 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 · 0
SEE ATTACHED - ATTACHMENT: [INVESTIGATION.PDF].
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. COMPONENT NOT REVISED: COTYLE "ANCA FIT?" SANS TROUS A/REVET. HAP 48 PPR67348 LOT U1088755. TIGE "ANCA FIT?" REV. HAP 1/3 PROXIMAL 15D PPR67620 LOT V01141668. INSERT CERAM "ANCA FIT?" 28/37 46-48/28 AL2.O3 BIOLOX FORTE PPR67508 LOT U1188767.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 647372 | PROFEMUR MODULAR FEMORAL NECK | HIP COMPONENT | LWJ | MICROPORT ORTHOPEDICS INC. | PHA01232 | T07127001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |