FDA Adverse Event
Injury
Summary report: N
REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X25
MDR report key: 15368480
·
Received September 7, 2022
Report
- Report Number
- 3005180920-2022-00681
- Event Type
- Injury
- Date Received
- September 7, 2022
- Date of Event
- August 12, 2022
- Report Date
- September 7, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- PHX
- UDI-DI
- 07630040708098
- PMA / PMN Number
- K171058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 02-SEP-2022. LOT 2113957: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-FEB-2022. EXPIRATION DATE: 2027-01-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
REVISION SURGERY PERFORMED 2 MONTHS AFTER THE PRIMARY DUE TO THREADED GLENOID BASEPLATE MOBILIZATION. THE SURGEON EXPLANTED THE BASEPLATE, SCREWS, GLENOSPHERE, PE LINER AND HUMERAL METAPHYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2486514 | REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X25 | SHOULDER GLENOID BASEPLATE | PHX | MEDACTA INTERNATIONAL SA | 04.01.0190 | 2113957 | 07630040708098 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |