FDA Adverse Event
Injury
Summary report: N
PROFEMUR NECK A/R 8DG LONG COBALT CHROME
MDR report key: 11131183
·
Received January 7, 2021
Report
- Report Number
- 3010536692-2021-00006
- Event Type
- Injury
- Date Received
- January 7, 2021
- Date of Event
- December 10, 2020
- Report Date
- February 8, 2021
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- JDL
- UDI-DI
- M684PHAC12341
- PMA / PMN Number
- K091423
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
Description of Event or Problem · 1
ALLEGEDLY, NECK BROKE. (BIG MALE PATIENT OVER (B)(6) LBS) ADDITIONAL INFORMATION RECEIVED ON 12/14/2020: PRODUCT INFORMATION, REVISION FACILITY AND DATE OF INCIDENT AND REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 32087 | PROFEMUR NECK A/R 8DG LONG COBALT CHROME | HIP COMPONENT | JDL | MICROPORT ORTHOPEDICS INC. | PHAC1234 | NI | M684PHAC12341 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |