MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5; SHOULDER GLENOSPHERE

Model Number	04.01.0169
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 6 months from primary it was observed that the baseplate and glenosphere were positioned very superior and needed to be revised.The cause of this is unknown.The surgeon revised the baseplate and glenosphere.
Additional Manufacturer Narrative
Batch review performed on 27 october 2022: lot 2105861: 194 items manufactured and released on 25-aug-2021.Expiration date: 2026-07-27.No anomalies found related to the problem.To date, (b)(6) items of the same lot have been sold without any similar reported event in the period of review.Additional implant involved: batch review performed on 27 october 2022 on reverse shoulder system 04.01.0190 threaded glenoid baseplate ø24.5x25 (k171058) lot.2110370 lot 2110370: (b)(6) items manufactured and released on 15-nov-2021.Expiration date: 2026-11-02.No anomalies found related to the problem.To date, 73 items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5
• Common Device Name: SHOULDER 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15779271
• Report Number: 3005180920-2022-00860
• Device Sequence Number: 5127113
• Product Code: PHX
• UDI-Device Identifier: 07630040706568
• UDI-Public: 07630040706568
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2022

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 Expiration Date: 07/27/2026
• Device Model Number: 04.01.0169
• Device Catalogue Number: 04.01.0169
• Device Lot Number: 2105861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2021
• 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: Female