FDA Adverse Event Injury Summary report: N

THREADED GLENOID BASEPLATE

MDR report key: 23478286 · Received November 5, 2025

Report

Report Number: 3005180920-2025-01068
Event Type: Injury
Date Received: November 5, 2025
Date of Event: October 16, 2025
Report Date: November 5, 2025
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: PHX
UDI-DI: 07630040708098
PMA / PMN Number: K171058
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

BATCH REVIEW PERFORMED ON 20-10-2025. REVERSE SHOULDER SYSTEM 04.01.0190 THREADED GLENOID BASEPLATEØ24.5X25 (K171058) LOT 185488A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MAR-2024 EXPIRATION DATE: 2029-02-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

Description of Event or Problem · 0

AT ABOUT 1 YEAR FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN. THE SURGEON, SUSPECTING IMPINGEMENT, REMOVED THE POLY, CUP AND GLENOSPHERE. UPON ATTEMPTING TO PLACE A NEW GLENOSPHERE, THE SURGEON NOTICED THE BASEPLATE WAS LOOSE. THE SURGEON DID NOT FIND ANY FRACTURES AND CAUSE OF LOOSINENG COULD NOT BE ESTABLISHED. THE SURGEON REVISED THE GLENOSPHERE, LINER, METAPHYSIS, AND BASEPLATE WITH MEDACTA IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2606209	THREADED GLENOID BASEPLATE	THREADED GLENOID BASEPLATE Ø24.5X25	PHX	MEDACTA INTERNATIONAL SA	04.01.0190	185488A	07630040708098

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR	Male	Required Intervention