FDA Adverse Event
Injury
Summary report: N
REVERSE SHOULDER SYSTEM 04.01.0152 GLENOID BASEPLATE Ø24.5X25
MDR report key: 14883694
·
Received July 1, 2022
Report
- Report Number
- 3005180920-2022-00503
- Event Type
- Injury
- Date Received
- July 1, 2022
- Date of Event
- June 3, 2022
- Report Date
- July 1, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- PHX
- UDI-DI
- 07630040706391
- PMA / PMN Number
- K170452
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 07-JUN-2022. LOT 2110376: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2021. EXPIRATION DATE: 2026-NOV-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: REVISION 2 MONTHS AFTER PRIMARY RSA IN A (B)(6) PATIENT DUE TO GLENOID FRACTURE. THE REASON OF THIS EVENT IS UNKNOWN. NO REASON TO SUSPECT THAT THIS EVENT IS DUE TO A FAULTY DEVICE.
Description of Event or Problem · 0
AT ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, REVISION SURGERY WAS PERFORMED DUE TO A GLENOID BONE FRACTURE. THE CAUSE OF THIS BONE FRACTURE IS NOT KNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1143099 | REVERSE SHOULDER SYSTEM 04.01.0152 GLENOID BASEPLATE Ø24.5X25 | SHOULDER GLENOID BASEPLATE | PHX | MEDACTA INTERNATIONAL SA | 04.01.0152 | 2110376 | 07630040706391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Male | Required Intervention |