MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 32XØ24.5; SHOULDER REVERSE GLENOSPHERE

Catalog Number	04.01.0178
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	01/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 january 2024 lot 189863: (b)(4) items manufactured and released on 06-mar-2019.Expiration date: 2024-02-26.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 components involved: batch review performed on 23 january 2024 reverse shoulder system 04.01.0151 glenoid baseplate ø24.5x15 (k170452) lot 2001979: (b)(4)items manufactured and released on 03-jun-2020.Expiration date: 2025-04-15.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Batch review performed on 23 january 2024 reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot 2003769: (b)(4) items manufactured and released on 18-feb-2021.Expiration date: 2026-02-08.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Batch review performed on 23 january 2024 reverse shoulder system 04.01.0116 humeral reverse hc liner ø32/+0mm (k170452) lot 183525: (b)(4) items manufactured and released on 26-jun-2018.Expiration date: 2023-06-10.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.Batch review performed on 23 january 2024 reverse shoulder system 04.01.0159 glenoid polyaxial locking screw - l22 (k170452) lot 2010121: (b)(4) items manufactured and released on 05-jan-2021.Expiration date: 2025-12-15.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.Batch review performed on 23 january 2024 reverse shoulder system 04.01.0161 glenoid polyaxial locking screw - l30 (k170452) lot 2010934: (b)(4) items manufactured and released on 05-mar-2021.Expiration date: 2026-02-17.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
At 2 years and 1 month from the primary, the patient came in reporting pain and the cause is unknown.The surgeon revised the humeral reverse liner, humoral reverse metaphysis, glenosphere, pegged baseplate and two screws.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 32XØ24.5
• Common Device Name: SHOULDER REVERSE 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18648767
• Report Number: 3005180920-2024-00031
• Device Sequence Number: 8264132
• Product Code: PHX
• UDI-Device Identifier: 07630040708135
• UDI-Public: 07630040708135
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: 2024
• 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): 02/06/2024

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: 02/26/2024
• Device Catalogue Number: 04.01.0178
• Device Lot Number: 189863
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2019
• 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: Unknown