FDA Adverse Event Injury Summary report: N

SHOULDER SYSTEM

MDR report key: 22043491 · Received May 19, 2025

Report

Report Number: 3005180920-2025-00444
Event Type: Injury
Date Received: May 19, 2025
Date of Event: April 22, 2025
Report Date: May 19, 2025
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: PHX
UDI-DI: 07630040706278
PMA / PMN Number: K170452
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

BATCH REVIEW PERFORMED ON 02 MAY 2025: LOT 2315955: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2023. EXPIRATION DATE: 2028-06-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANT INVOLVED, BATCH REVIEW PERFORMED ON 02 MAY 2025: REVERSE SHOULDER SYSTEM 04.01.0269 SENSITIN GLENOSPHERE 36XØ24.5 (K203755) LOT 2404992: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-09-2024. EXPIRATION DATE: 2029-08-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 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

THE PATIENT HAD A LUXATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE IS UNKNOWN. AT ABOUT 5 MONTHS FROM PRIMARY THE SURGEON REVISED THE GLENOSPHERE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2142919	SHOULDER SYSTEM	HUMERAL REVERSE HC LINER Ø36/+3MM	PHX	MEDACTA INTERNATIONAL SA	04.01.0120	2315955	07630040706278

Patients

Seq	Age	Sex	Outcome	Treatment
1	87 YR	Female	Required Intervention