FDA Adverse Event
Malfunction
Summary report: N
ARROW
MDR report key: 14464335
·
Received May 20, 2022
Report
- Report Number
- 3003898228-2022-00005
- Event Type
- Malfunction
- Date Received
- May 20, 2022
- Date of Event
- April 19, 2022
- Report Date
- September 26, 2022
- Manufacturer
- FH INDUSTRIE
- Product Code
- KWS
- UDI-DI
- 03661489651458
- PMA / PMN Number
- K112193
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
THE SURGEON REVIEWED A PATIENT WHOSE INITIAL OPERATION TOOK PLACE ON (B)(6). THE HUMERAL COMPONENT WAS DISSOCIATED FROM THE GLENOID BASE PLATE.
Description of Event or Problem · 0
THE SURGEON REVIEWED A PATIENT WHOSE INITIAL OPERATION TOOK PLACE ON JULY 11. THE HUMERAL COMPONENT WAS DISSOCIATED FROM THE GLENOID BASE PLATE.
Description of Event or Problem · 0
THE SURGEON REVIEWED A PATIENT WHOSE INITIAL OPERATION TOOK PLACE ON JULY 11. THE HUMERAL COMPONENT WAS DISSOCIATED FROM THE GLENOID BASE PLATE.
Description of Event or Problem · 0
THE SURGEON REVIEWED A PATIENT WHOSE INITIAL OPERATION TOOK PLACE ON (B)(6). THE HUMERAL COMPONENT WAS DISSOCIATED FROM THE GLENOID BASE PLATE.
Description of Event or Problem · 0
THE SURGEON REVIEWED A PATIENT WHOSE INITIAL OPERATION TOOK PLACE ON JULY 11. THE HUMERAL COMPONENT WAS DISSOCIATED FROM THE GLENOID BASE PLATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 540081 | ARROW | ARROW STD HUMERAL INSERT D39 H05 | KWS | FH INDUSTRIE | 265145 | E04728 | 03661489651458 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |