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

Model Number	04.01.0208
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 8 months after the primary surgery, the patient came in reporting pain due to the disassociation of the glenosphere from the baseplate.The surgeon revised the glenosphere, screw and liner and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 23-jun-2022: lot 2003816a: (b)(4) manufactured and released on 20-jan-2021.Expiration date: 2026-01-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Lot 2003816: 11 items manufactured and released on 03-nov-2020.Expiration date: 2025-10-23.No anomalies found related to the problem.Additional device involved: batch review performed on 23-jun-2022: reverse shoulder system 04.01.0191 threaded glenoid baseplate ø24.5x30 (k171058) lot 1906800: (b)(4) items manufactured and released on 12-feb-2020.Expiration date: 2025-02-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medacta medical affairs manager: revision 8 months after the primary rsa in a male patient due to the disassociation of the glenosphere from the baseplate.From the radiographic images, it is visible the glenophere dissociated from the baseplate.This event possibly happened due to the fact that one of the bone screws could not reach the final position and this prevented the glenosphere from finding perfect stability on the lateral surface on the taper spigot of baseplate, despite of central glenophere screw being properly tightened.The surgeon revised the glenosphere, screw and liner and the surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39XØ24.5
• Common Device Name: SHOULDER GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15028118
• Report Number: 3005180920-2022-00539
• Device Sequence Number: 17695857
• Product Code: HSD
• UDI-Device Identifier: 07630040728072
• UDI-Public: 07630040728072
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K193175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2026
• Device Model Number: 04.01.0208
• Device Catalogue Number: 04.01.0208
• Device Lot Number: 2003816A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2021
• 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: Other; Required Intervention
• Patient Sex: Male
• Patient Race: White