FDA Adverse Event Injury Summary report: N

SHOULDER SYSTEM

MDR report key: 20974729 · Received December 19, 2024

Report

Report Number: 3005180920-2024-01079
Event Type: Injury
Date Received: December 19, 2024
Date of Event: November 29, 2024
Report Date: December 19, 2024
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: PHX
PMA / PMN Number: K170452
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

BATCH REVIEW PERFORMED ON 19-DEC-2024. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-AUG-2023. EXPIRATION DATE: 2028-07-23. 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 INVOLVED DEVICES: REVERSE SHOULDER SYSTEM 04.01.0170 GLENOSPHERE - Ø39X24.5 (K170452) LOT. 2003761 BATCH REVIEW PERFORMED ON 19-DEC-2024 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-NOV-2020. EXPIRATION DATE: 2025-10-21. 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. 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 2 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A JOINT LUXATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE, METAPHYSIS AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2098983	SHOULDER SYSTEM	REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM	PHX	MEDACTA INTERNATIONAL SA	04.01.0123	2308351

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR	Unknown	Required Intervention