MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; LAT. GLENOSPHERE 32XØ24.5

Model Number	04.01.0206
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Date of Event	06/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 july 2026 reverse shoulder system 04.01.0206 lat.Glenosphere 32xd 24.5 (k193175) lot: 2520890: (b)(4) items manufactured and released on 24-oct-2025.Expiration date: 19-oct-2030.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0488 hum.Rev.E-cross liner d 32/+3 - small (k250644) lot: 2509197: (b)(4) items manufactured and released on 30-apr-2025.Expiration date: 15-apr-2030.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Root cause: based on the available information, the reported instability may be related to soft tissue laxity, which is a known possible complication following tsa, as soft tissues may stretch over time and provide insufficient stability.No evidence of device malfunction was identified, and the device history record review did not reveal any discrepancies.
Event or Problem Description
Revision surgery due to instability after about 1 months from primary.The surgeon revised the d 32/+3 small reverse liner to a d 36/+6 small reverse liner and revised the 32xd 24.5 glenosphere to a 36xd 24.5 glenosphere.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: LAT. GLENOSPHERE 32XØ24.5
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 25813743
• Report Number: 3005180920-2026-00668
• Device Sequence Number: 12271637
• Product Code: HSD
• UDI-Device Identifier: 07630040728058
• UDI-Public: 07630040728058
• Combination Product (Y/N): N
• PMA/510(K) Number: K193175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/14/2026

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: 04.01.0206
• Device Lot Number: 2520890
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2025
• 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: 80 YR
• Patient Sex: Female
• Patient Race: White