MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5; SHOULDER GLENOSPHERE

Catalog Number	04.01.0169
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 may 2024: lot 2347102: (b)(4) items manufactured and released on 09-april-2024.Expiration date: 2029-03-27.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 device involved batch review performed on 28 may 2024 reverse shoulder system 04.01.0121 humeral reverse hc liner ø36/+6mm (k170452) lot 2337209: (b)(4) items manufactured and released on 12-dec-2023.Expiration date: 2028-11-22.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.Reverse shoulder system 04.01.0216 long humeral diaphysis - l160 - 9 (k192967) lot 2302357: (b)(4) items manufactured and released on 14-jun-2023.Expiration date: 2028-05-29.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.Clinical evaluation performed by medacta medical affairs manager: second revision few days after the first revision due to liner-glenosphere dislocation and loosening of the diaphysis.From the radiographic image the stem may have been undersized while the dislocation may have happened due to insufficient re-establishment of soft tissue tension after the operation.In fact the surgeon in the revision cemented the stem and applied more lateralization.There is no reason to suspect a malfunctioning device.
Event or Problem Description
The patient had a primary shoulder surgery on the (b)(6) 2021.On (b)(6) 2024, the patient came in due to signs of an infection (propioni-bacterium).All components were successfully revised.Reimplantation of new reverse shoulder components, bone graft and long humeral stem.On (b)(6) 2024, the patient underwent revision surgery due to liner-glenosphere dislocation and loosening of the diaphysis.The surgeon explanted the long humeral stem, the metaphysis, the liner and the glenosphere (to test the stability of the baseplate and the graft).Reimplantation of a new long humeral stem (cemented) with a new metaphysis and liner +6mm (155 degrees) and a lateralized glenosphere.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5
• Common Device Name: 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: 19575477
• Report Number: 3005180920-2024-00434
• Device Sequence Number: 3980219
• 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: 2024
• 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): 06/20/2024

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: 2347102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2024
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 87 KG