MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 39X24.5; REVERSE SHOULDER GLENOSPHERE

Model Number	04.01.0170
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12-jan-2021: lot 1910953: (b)(4) items manufactured and released on 04-jun-2020.Expiration date: 24-may-2025.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional implant involved: reverse shoulder system 04.01.0124 humeral reverse hc liner ø39/+6mm (k170452) lot.1907768.Batch review performed on 12 january 2021: lot 1907768: (b)(4) items manufactured and released on 07-nov-2019.Expiration date: 2024-10-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.
Event or Problem Description
Second revision surgery due to shoulder luxation (instability) of the glenosphere from the liner, 1 month after the previous operation.During the revision surgery the metaphysis, glenosphere and liner were revised.The new glenosphere is lateralized and the liner is +3mm.
Additional Manufacturer Narrative
The visual inspection was performed on wednesday, 27th january 2021 by medacta r&d department.The liner does not present any signs of damage.The glenosphere is partially scratched and dull, probably due to friction with the "reverse metaphysis" occurred after the dislocation.The reverse metaphysis shows minor bone and hydroxyapatite residuals on the coated surface.The outer cylindrial surface is damaged on the medial side presumably due to contact with the glenosphere.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 39X24.5
• Common Device Name: REVERSE SHOULDER GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11153954
• Report Number: 3005180920-2021-00045
• Device Sequence Number: 11616878
• Product Code: PHX
• UDI-Device Identifier: 07630040706575
• UDI-Public: 07630040706575
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 02/26/2021

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 Expiration Date: 05/24/2025
• Device Model Number: 04.01.0170
• Device Catalogue Number: 04.01.0170
• Device Lot Number: 1910953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention