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
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	08/22/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005180920-2023-00715
• Device Sequence Number: 12123156
• Product Code: PHX
• UDI-Device Identifier: 07630040706568
• UDI-Public: 07630040706568
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/03/2025
• Device Catalogue Number: 04.01.0169
• Device Lot Number: 1910099
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White