MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5; REVERSE SHOULDER 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	11/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 november 2023: lot 2311286: 100 items manufactured and released on 03-aug-2023.Expiration date: 2028-jul-17.No anomalies found related to the problem.To date, 36 items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs department: revision after one month from the first revision surgery due to joint luxation.Even if with a lateralized glenosphere, it may be possible that after the second revision there was insufficient re-establishment of soft tissue tension.No further conclusion can be drawn with the elements at hand.Additional implant involved, batch review performed on 23 november 2023: reverse shoulder system 04.01.0119 humeral reverse hc liner ø36/+0mm (k170452) lot 2314998: 89 items manufactured and released on 08-aug-2023.Expiration date: 2028-jul-23.No anomalies found related to the problem.To date, 69 items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
Revision surgery due to shoulder luxation was performed about 3 months after the previous revision surgery.The patient was previously revised due to a traumatic event that caused a bone fracture.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5
• Common Device Name: REVERSE SHOULDER 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: 18244674
• Report Number: 3005180920-2023-00937
• Device Sequence Number: 6600666
• Product Code: PHX
• UDI-Device Identifier: 07630040706568
• UDI-Public: 07630040706568
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 12/01/2023

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: 2311286
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2023
• 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: 66 YR
• Patient Sex: Male