MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 36X24.5; SHOULDER IMPLANT GLENOSPHERE

Model Number	04.01.0169
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15-apr-2021: lot 2003385: (b)(4) items manufactured and released on 03-jul-2020.Expiration date: 2025-07-01.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.Another device involved: batch review performed on 23-apr-2021: reverse shoulder system 04.01.0120 humeral reverse hc liner ¿36/+3mm (k170452) lot 2006591: (b)(4) items manufactured and released on 22-oct-2020.Expiration date: 2025-10-18.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.
Event or Problem Description
Revision surgery performed due to recurrent dislocations.The patient has dementia and is non-compliant, which could be the reason for the repetitive dislocations.The surgeon performed a salvage-hemiarthroplasty on the patient on (b)(6) 2021, 3 days after the last revision surgery where only the liner was revised.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 36X24.5
• Common Device Name: SHOULDER IMPLANT GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11723776
• Report Number: 3005180920-2021-00328
• Device Sequence Number: 17101473
• Product Code: PHX
• UDI-Device Identifier: 07630040706568
• UDI-Public: 07630040706568
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 04/26/2021

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: 07/01/2025
• Device Model Number: 04.01.0169
• Device Catalogue Number: 04.01.0169
• Device Lot Number: 2003385
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2021
• Initial Report FDA Received Date: 04/26/2021
• 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