FDA Adverse Event
Malfunction
Summary report: N
HUMERIS
MDR report key: 11342777
·
Received February 18, 2021
Report
- Report Number
- 3009532798-2021-00001
- Event Type
- Malfunction
- Date Received
- February 18, 2021
- Date of Event
- January 21, 2021
- Report Date
- February 4, 2021
- Manufacturer
- FX SOLUTIONS
- Product Code
- HSD
- UDI-DI
- 03701037300480
- PMA / PMN Number
- K111097
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
THIS WAS INITIALLY REPORTED BY OUR IMPORTER UNDER MDR 3014128390-2021-00001.
Description of Event or Problem · 1
PATIENT REVISED ON (B)(6) 2021, FOLLOWING A DISLOCATION WHICH CAUSED A TEAR IN THE ROTATOR CUFF. SURGEON CONVERTED TOTAL ANANATOMIC TO A REVERSE ; EXPLANTING THE SIZE S 3-4 PEG GLENOID, 43X17 OFFSET COCR HEAD, AND +0MM DOUBLE TAPER ; THEN IMPLANTING 135/145 36/+6 STABILITY CUP, 35MM CENTERED GLENOSPHERE WITH SCREW, 24 MM BASEPLATE WITH CENTRAL SCREW, AND 4 LOCKING SCREWS. THIS WAS INITIALLY REPORTED BY OUR IMPORTER UNDER MDR 3014128390-2021-00001.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 243864 | HUMERIS | SHOULDER PROSTHESIS | HSD | FX SOLUTIONS | DIAMETER 43 mm OFFSET | L1734 | 03701037300480 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization| R |