FDA Adverse Event
Injury
Summary report: N
HUMERIS
MDR report key: 19644107
·
Received July 1, 2024
Report
- Report Number
- 3009532798-2024-00073
- Event Type
- Injury
- Date Received
- July 1, 2024
- Date of Event
- June 3, 2024
- Report Date
- July 1, 2024
- Manufacturer
- FX SHOULDER SOLUTIONS
- Product Code
- PHX
- UDI-DI
- 03701037301593
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE EVENT TOOK PLACE OUTSIDE THE UNITED STATES (IN FRANCE) AND WAS ASSOCIATED WITH A PRODUCT THAT IS ALSO CLEARED FOR THE MARKET IN THE UNITED STATES.
Description of Event or Problem · 0
THE PATIENT WAS REVISED DUE TO AN INFECTION ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2018. A CUP, A GLENOSPHERE, A METAGLENE AND A STEM WERE EXPLANTED. A SPACER WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 573200 | HUMERIS | REVERSED SHOULDER PROTHESIS | PHX | FX SHOULDER SOLUTIONS | L1206 | 03701037301593 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H |