MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE - Ø36X24.5; SHOULDER REVERSE SYSTEM GLENOSPHERE

Catalog Number	04.01.0169
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery for shoulder luxation 4 days after primary.Glenosphere and liner revised successfully.
Additional Manufacturer Narrative
Batch review performed on 21 december 2023: lot 2218416: (b)(4) items manufactured and released on 28-sep-2022.Expiration date: 2027-09-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Clinical evaluation performed by medical affairs department: revision 4 days after the index surgery due to shoulder luxation.From the radiographic image a cerclage is visible but no info was given regarding the necessity of a cerclage and the possible relevance to the subsequent dislocation.Luxations are normal originated by insufficient re-establishment of soft tissue tension after the operation.No further conclusion can be drawn with the elements at hand.Additional implant involved.Batch review performed on 21 december 2023 on reverse shoulder system 04.01.0119 humeral reverse hc liner ø36/+0mm (k170452) lot.2247430 lot 2247430: (b)(4) items manufactured and released on 17-apr-2023.Expiration date: 2028-04-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event in the period of review.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE - Ø36X24.5
• 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: 18483998
• Report Number: 3005180920-2023-01033
• Device Sequence Number: 2723084
• Product Code: PHX
• UDI-Device Identifier: 07630040706568
• UDI-Public: 07630040706568
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 01/10/2024

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 Catalogue Number: 04.01.0169
• Device Lot Number: 2218416
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2022
• 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 Age: 78 YR
• Patient Sex: Female