MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ27; SHOULDER GLENOSPHERE

Model Number	04.01.0172
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 4 months after the primary, revision of methaphysis, glenosphere, and liner following shoulder luxation.The deficit of the muscle-tendon complex, linked to inactivity and mass, may have reduced joint stability.
Additional Manufacturer Narrative
Batch review performed on 31 may 2022.Lot 2109115: (b)(4) manufactured and released on 09-sep-2021.Expiration date: 2026-08-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Reverse shoulder system 04.01.0120 humeral reverse hc liner ø36/+3mm (k170452) lot 2104816: (b)(4) items manufactured and released on 22-june-2021.Expiration date: 2026-06-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medical affairs department.Posterior dislocation in rsa few months after the operation.The patient is severly overweight; most probably, the deficit of the muscle-tendon complex, linked to inactivity and mass, may have reduced joint stability.No reason to suspect a faulty device at the origin of this adverse event.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ27
• Common Device Name: SHOULDER GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14839514
• Report Number: 3005180920-2022-00490
• Device Sequence Number: 11948007
• Product Code: PHX
• UDI-Device Identifier: 07630040706599
• UDI-Public: 07630040706599
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 06/28/2022

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: 08/24/2026
• Device Model Number: 04.01.0172
• Device Catalogue Number: 04.01.0172
• Device Lot Number: 2109115
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2021
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White