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

Model Number	04.01.0208
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
References and lots number not provided.Document review cannot be performed.Clinical evaluation: post-operative imaging revealed dissociation of the glenosphere from the baseplate.A revision procedure has been done around 4 months after the primary surgery.With the available information, the exact cause cannot be confirmed.However, the pattern is consistent with incomplete taper engagement during the primary surgery rather than a device defect.Possible contributing factors include a protruding baseplate screw head preventing full seating or improper assembly of the glenosphere, leading to gradual micromotion and eventual dissociation.Overall, there is no reason to suspect a malfunctioning device.Root cause: although the root cause cannot be confirmed based on the available information, it may be possible that the glenosphere was not correctly aligned and fixed during the primary surgery.
Event or Problem Description
About 4 months and a half after the primary surgery, revision surgery was performed dueto glenosphere screw unscrewing and glenosphere dissociation from the baseplate.
Additional Manufacturer Narrative
Batch review performed on 11 march 2026.Reverse shoulder system 04.01.0208 lat.Glenosphere 39xø24.5 (k193175) lot 2503228: (b)(4).Manufactured and released on 25-apr-2025.Expiration date: 10-apr-2030.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0151 glenoid baseplate - ø24.5x15 (k170452) lot 2508596: (b)(4) manufactured and released on 30-jun-2025.Expiration date: 10-june-2030.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.Root cause: although the root cause cannot be confirmed based on the available information, it may be possible that the glenosphere was not correctly aligned and fixed during the primary surgery.There is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.Additional information: ref and lot, knumber, batch review, annex b to be added: 3331, updated conclusions.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: LAT. GLENOSPHERE 39XØ24.5
• 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: 24518510
• Report Number: 3005180920-2026-00137
• Device Sequence Number: 9724675
• Product Code: HSD
• UDI-Device Identifier: 07630040728072
• UDI-Public: 07630040728072
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K193175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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: 04.01.0208
• Device Lot Number: 2503228
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2025
• 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 Sex: Unknown