MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0169 GLENOSPHERE 36XØ24.5; REVERSE SHOULDER SYSTEM GLENOSPHERE

Catalog Number 04.01.0169

Device Problem Device Appears to Trigger Rejection (1524)

Event Date 08/22/2023

Event Type  Injury  

Event Description

At about 1 month and 2 weeks after the primary, the patient came in reporting infection and the pathogen is unknown.The surgeon revised successfully the metaphysis, liner and glenosophere.

Manufacturer Narrative

Batch review performed on 28-aug-2023.Lot 1910099: (b)(4) items manufactured and released on 13-may-2020.Expiration date: 2025-05-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported case during the period of review.Clinical evaluation performed by medical affairs department: early infection in cementless rsa, 1 month and 2 weeks after primary operation.Infection is a known possible adverse event following every surgery, including rsa's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Other devices involved: reverse shoulder system 04.01.0111 humeral reverse metaphysis +9mm/0° (k170452) lot 2001817: (b)(4) items manufactured and released on 10-jul-2020.Expiration date: 2025-07-02.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.Reverse shoulder system 04.01.0120 humeral reverse hc liner ø36/+3mm (k170452) lot 2248488: (b)(4) items manufactured and released on 03-may-2023.Expiration date: 2028-04-12.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.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0169 GLENOSPHERE 36XØ24.5
• Type of Device: REVERSE SHOULDER SYSTEM GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17780187
• MDR Text Key: 323815910
• Report Number: 3005180920-2023-00715
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K170452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.01.0169
• Device Lot Number: 1910099
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White