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

Model Number	04.01.0169
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022.Lot 1910952b: 5 items manufactured and released on (b)(6) 2021.Expiration date: 2026-nov-22.No anomalies found related to the problem.To date, 2 items of the same lot have been sold with no similar reported event during the period of review.Original lot 1910952: 113 items manufactured and released on 03-jun-2020.Expiration date: 2025-may-24.No anomalies found related to the problem.To date, 103 items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation: partial revision 1 month after rsa due to joint dislocation.The reason of the adverse event is unknown.Liner was revised maintaining the same thickness of the liner (+6mm) but changing the ccd angle at 155° in order to have more stability.It may be possible that the dislocation occured due to laxity of the soft tissues.We do not see any reason to suspect a faulty device.Additional implant involved: batch review performed on (b)(6) 2022: reverse shoulder system 04.01.0121 humeral reverse hc liner ø36/+6mm (k170452) lot 2104818: 26 items manufactured and released on 23-jun-2021.Expiration date: 2026-jun-10.No anomalies found related to the problem.To date, 11 items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
Revision surgery performed due to joint luxation 1 month after the primary surgery.Only replaced insert with same thickness but 155° because the articulation remained very stable once reduced.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5
• 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: 14801073
• Report Number: 3005180920-2022-00485
• Device Sequence Number: 4652888
• Product Code: PHX
• UDI-Device Identifier: 07630040706568
• UDI-Public: 07630040706568
• 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): 06/24/2022

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 Model Number: 04.01.0169
• Device Catalogue Number: 04.01.0169
• Device Lot Number: 1910952B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2021
• 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 Sex: Unknown