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	06/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 july 2024 lot 2305239: (b)(4) manufactured and released on 10-may-2023.Expiration date: 2028-04-17.No anomalies found related to the problem.To date, 16 items of the same lot have been sold with no similar reported event during the period of review.Visual inspection performed by r&d project manager the glenosphere has a partially dull articulating surface, likely following friction with the reverse metaphysis after the joint luxation.The glenosphere screw does not have any sign of damage.This demonstrates that the screw was still firmly fixed at the time of revision.The reverse metaphysis is partially polished on the medial side.This is due to friction with the glenosphere after the joint luxation.Bone residuals are visible on the ha-coated portion.The liner does not present any sign of damage on either the articulating surface, the rim nor the outer surface.Due to the integrity of the liner, this dislocation does not seem to be associated with friction of the liner with the scapula or with a lever-out phenomenon.The event is rather associated with soft tissue balance or joint tension.Additional implant revised: batch review performed on 01 july 2024 on reverse shoulder system 04.01.0123 humeral reverse hc liner ø39/+3mm (k170452) lot.2335877.Lot 2335877: (b)(4) manufactured and released on 30-nov-2023.Expiration date: 2028-11-18.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
Revision surgery at about 4 months from the primary due to joint luxation.There were previous dislocations which have been treated manually.The surgeon revised metaphysis, glenosphere and liner and completed the surgery successfully.

• 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: 19837127
• Report Number: 3005180920-2024-00536
• Device Sequence Number: 12698077
• Product Code: HSD
• UDI-Device Identifier: 07630040728072
• UDI-Public: 07630040728072
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2024

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: 04.01.0208
• Device Lot Number: 2305239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2023
• 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 Sex: Male
• Patient Weight: 90 KG