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

Model Number	04.01.0170
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2018 the patient had a primary anatomic shoulder surgery.On (b)(6) 2024, the surgeon converted the patient from an anatomical shoulder to a reverse shoulder due to the patient reporting pain related to a rotator cuff failure.On (b)(6) 2024, the patient came in reporting pain due to a dislocation of the glenosphere from the liner.The surgeon closed reduced under anesthesia the patient and no implants were revised.The case was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 23-12-2024 lot 1910953: (b)(4) items manufactured and released on 04-06-2020.Expiration date: 2025-05-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 2 other similar reported events.Additional item involved in the event; batch review performed on 23-12-2024.Reverse shoulder system 04.01.0122 humeral reverse hc liner ø39/+0mm (k170452) lot.2117046 lot 2117046: (b)(4) items manufactured and released on 12-01-2022.Expiration date: 2027-01-02.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.Based on the information available no definitive root cause can be established, while 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.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: 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: 21167796
• Report Number: 3005180920-2024-01149
• Device Sequence Number: 11830444
• Product Code: PHX
• UDI-Device Identifier: 07630040706575
• UDI-Public: 07630040706575
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/24/2025
• Device Model Number: 04.01.0170
• Device Lot Number: 1910953
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2020
• 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: Other
• Patient Sex: Male