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

Model Number	04.01.0170
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain due to a dislocation of the liner from the glenosphere.The cause of the dislocation is unknown.At 1 month after the primary surgery, the surgeon revised the glenosphere and liner and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 17 january 2022.Lot 189745: (b)(4) items manufactured and released on 27-feb-2019.Expiration date: 2024-feb-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 1 similar reported event.Additional item involved in the event, batch review performed on 17 january 2022: reverse shoulder system 04.01.0124 humeral reverse hc liner ø39/+6mm (k170452) lot.175050 lot 175050: (b)(4) items manufactured and released on 27-sep-2017.Expiration date: 2022-sep-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 3 similar reported events.
Additional Manufacturer Narrative
Batch review performed on 17 january 2022.Lot 189745: (b)(4) items manufactured and released on 27-feb-2019.Expiration date: 2024-feb-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 1 similar reported event.Additional item involved in the event, batch review performed on 17 january 2022: reverse shoulder system 04.01.0124 humeral reverse hc liner ø39/+6mm (k170452) lot.175050 lot 175050: (b)(4) items manufactured and released on 27-sep-2017.Expiration date: 2022-sep-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 3 similar reported events.
Event or Problem Description
The patient came in reporting pain due to a dislocation of the liner from the glenosphere.The cause of the dislocation is unknown.At 1 month after the primary surgery, the surgeon revised the glenosphere and liner and the surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM 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: 13469562
• Report Number: 3005180920-2022-00083
• Device Sequence Number: 3963498
• 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: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2022

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: 02/18/2024
• Device Model Number: 04.01.0170
• Device Catalogue Number: 04.01.0170
• Device Lot Number: 189745
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2019
• 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: Male