MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 42XØ27

Model Number	04.01.0212
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 9 jan 2025: lot: 2402053: (b)(4) items manufactured and released on 21-may-2024.Expiration date: 2029-may-02.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.Additional revised device.Batch review performed on 9 jan 2025: reverse shoulder system 04.01.0155 glenoid baseplate ø27x25 (k170452) lot: 2405154: (b)(4) items manufactured and released on 01-jul-2024.Expiration date: 2029-jun-12.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.Clinical evaluation performed by medacta medical affairs manager: revision surgery about 2 months after the primary rsa, due to partial dissociation between the baseplate and the glenosphere.According to report the reason of this dissociation is due to the unscrewing of the glenosphere screw.From the radiographic image the dissociation of the two parts is visible.Since the glenosphere guide was not used during the primary surgery, it may be possible that the glenosphere was not fully seated on the baseplate taper.For instance, if the guide had not been used, the central screw may give the impression of a good tightening but the morse taper at the perimeter of the baseplate is not correctly engaged and with time the two implants may dissociate.Lot: 2405154: (b)(4) items manufactured and released on 01-jul-2024.Expiration date: 2029-jun-12.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.
Event or Problem Description
About 6 weeks after the primary surgery, the x-rays showed that the glenosphere was partially dissociated from the baseplate due to glenosphere screw unscrewing.The patient had no symptoms.Revision surgery has been performed, glenosphere and glenosphere screw revised.Glenosphere guide was not used during the primary surgery.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 42XØ27
• 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: 21251764
• Report Number: 3005180920-2025-00012
• Device Sequence Number: 9117417
• Product Code: HSD
• UDI-Device Identifier: 07630040728119
• UDI-Public: 07630040728119
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K193175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.01.0212
• Device Lot Number: 2402053
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown