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

Catalog Number	04.01.0208
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 may 2024.Lot 2317075a: (b)(4) items manufactured and released on 12-dec-2023.Expiration date: 2028-11-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Additional involved implant: batch review performed on 06 may 2024 on reverse shoulder system 04.01.0123 humeral reverse hc liner ø39/+3mm (k170452) lot.2312761 lot 2312761: (b)(4) items manufactured and released on 14-aug-2023.Expiration date: 2028-07-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.
Event or Problem Description
Revision surgery due to shoulder luxation at about 3 months after primary and the cause is unknown.The surgeon revised the metaphysis and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 13 may 2024.Lot 2243585: (b)(4) items manufactured and released on 16-dec-2022.Expiration date: 2027-11-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.Information reported in this follow up.On 10 may 2024, it was noted that the glenosphere was not reported as product involved, while metaphysis was, due to a mistake.Emdr has been corrected with: details of the glenosphere; batch review of the glenosphere.

• Brand Name: REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39XØ24.5
• Common Device Name: SHOULDER REVERSE SYSTEM 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: 19248900
• Report Number: 3005180920-2024-00302
• Device Sequence Number: 6397019
• Product Code: HSD
• UDI-Device Identifier: 07630040728072
• UDI-Public: 07630040728072
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K193175
• 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,Followup
• Report Date (Section B): 06/05/2024
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: 04.01.0208
• Device Lot Number: 2243585
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2022
• 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