FDA Adverse Event
Injury
Summary report: N
HUMELOCK REVERSED
MDR report key: 9834117
·
Received March 16, 2020
Report
- Report Number
- 3009532798-2020-19346
- Event Type
- Injury
- Date Received
- March 16, 2020
- Date of Event
- June 24, 2019
- Report Date
- March 11, 2020
- Manufacturer
- FX SOLUTIONS
- Product Code
- PHX
- PMA / PMN Number
- K162455
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
THE EVENT TOOK PLACE OUTSIDE OF THE UNITED STATES (IN (B)(6)) AND WAS ASSOCIATED WITH A PRODUCT THAT IS ALSO CLEARED FOR THE MARKET WITHIN THE UNITED STATES.
Description of Event or Problem · 1
REVISION SURGERY DUE TO A DISLOCATION OCCURRED (B)(6) 2019. 36/+3 HUMERAL CUP WAS REMOVED AND REPLACED BY 36/+6 HUMERAL CUP. PRIMARY SURGERY OCCURRED (B)(6) 2018.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 300508 | HUMELOCK REVERSED | REVERSED SHOULDER PROTHESIS | PHX | FX SOLUTIONS | M1443 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |