FDA Adverse Event
Injury
Summary report: N
REVERSE SHOULDER SYSTEM 04.01.0191 THREADED GLENOID BASEPLATE Ø24.5X30
MDR report key: 13904001
·
Received March 25, 2022
Report
- Report Number
- 3005180920-2022-00201
- Event Type
- Injury
- Date Received
- March 25, 2022
- Date of Event
- February 25, 2022
- Report Date
- March 25, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- PHX
- UDI-DI
- 07630040715478
- PMA / PMN Number
- K171058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON (B)(6) 2022: LOT 1904749: 130 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2019. EXPIRATION DATE: (B)(6) 2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 113 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 0
AT 7 MONTHS FROM PRIMARY SURGERY THE SURGEON REVISED ALL THE SHOULDER COMPONENTS FOR GLENOID BASEPLATE LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 851096 | REVERSE SHOULDER SYSTEM 04.01.0191 THREADED GLENOID BASEPLATE Ø24.5X30 | THREADED GLENOID BASEPLATE | PHX | MEDACTA INTERNATIONAL SA | 04.01.0191 | 1904749 | 07630040715478 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |