FDA Adverse Event Injury Summary report: N

REVERSE SHOULDER SYSTEM 04.01.0123 HUMERAL REVERSE HC LINER Ø39/+3MM

MDR report key: 15461994 · Received September 21, 2022

Report

Report Number: 3005180920-2022-00705
Event Type: Injury
Date Received: September 21, 2022
Date of Event: August 22, 2022
Report Date: September 21, 2022
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: PHX
UDI-DI: 07630040706308
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 23-AUG-2022: LOT 2112133: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-OCT-2021. EXPIRATION DATE: 2026-09-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 23-AUG-2022: REVERSE SHOULDER SYSTEM 04.01.0211 LAT. GLENOSPHERE 39XØ27 (K193175) LOT 2117353: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAR-2022. EXPIRATION DATE: 2027-02-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

Description of Event or Problem · 0

AT ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE REVERSE LINER, METAPHYSIS AND LATERALIZED GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2791998	REVERSE SHOULDER SYSTEM 04.01.0123 HUMERAL REVERSE HC LINER Ø39/+3MM	SHOULDER HUMERAL REVERSE HC LINER	PHX	MEDACTA INTERNATIONAL SA	04.01.0123	2112133	07630040706308

Patients

Seq	Age	Sex	Outcome	Treatment
1		Male	Required Intervention