MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ24.5; SHOULDER REVERSE GLENOSPHERE

Catalog Number	04.01.0170
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Primary surgery (b)(6) 2023 after a tonic clonic seizure with posterior luxations on both the left and right shoulder.Bone grafts used.1st revision surgery performed (b)(6) 2024 after recurrent shoulder luxations on the right side and glenoid baseplate loosening.Change of baseplate, screws, glenosphere and liner.Humeral diaphysis and metaphysis stay in situ.2nd revision surgery was performed on (b)(6) 2024 after persistent shoulder luxations.Change of glenosphere and liner.Baseplate, humeral diaphysis and metaphysis stay in situ.
Additional Manufacturer Narrative
Batch review performed on 07 jun 2024 lot 2335892: (b)(4) items manufactured and released on 16-jan-2024.Expiration date: 2028-12-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.Clinical evaluation performed by medica affairs department: second revision 1 month after previous revision due to luxation of joint.A lateralized glenosphere was implanted on top of the glenoid reconstruction baseplate in order to give enough soft tissue tensioning to prevent further luxations.There is no reason to suspect a malfunctioning device.Additional components involved in the event: batch review performed on 07 jun 2024.Reverse shoulder system 04.01.0124 humeral reverse hc liner ø39/+6mm (k170452) lot 2311276: (b)(4) items manufactured and released on 14-aug-2023.Expiration date: 2028-07-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no other similar reported event during the period of review.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ24.5
• Common Device Name: SHOULDER REVERSE 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: 19632759
• Report Number: 3005180920-2024-00468
• Device Sequence Number: 8673815
• Product Code: PHX
• UDI-Device Identifier: 07630040706575
• UDI-Public: 07630040706575
• 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: 2024
• Device Explanted Year: 2024
• 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): 06/28/2024

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 Catalogue Number: 04.01.0170
• Device Lot Number: 2335892
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2024
• 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: 58 YR
• Patient Sex: Female