MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø32/+6MM; SHOULDER LINER

Model Number	04.01.0118
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022.Lot 173416: 78 items manufactured and released on (b)(6) 2017.Expiration date: 2022-06-08.No anomalies found related to the problem.To date, 32 items of the same lot have been sold with three other similar reported events during the period of review.Additional implant involved: batch review performed on (b)(6) 2022 on reverse shoulder system 04.01.0206 lat.Glenosphere 32xø24.5 (k193175) lot.1811033a lot 1811033: 4 items manufactured and released on (b)(6) 2021.Expiration date: 2026-01-17.No anomalies found related to the problem.To date, 2 items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
Revision surgery performed at about 8 months after the primary due to joint luxation and the cause is unknown.The surgeon revised successfully the metaphysis and the liner.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø32/+6MM
• Common Device Name: SHOULDER LINER
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15779261
• Report Number: 3005180920-2022-00857
• Device Sequence Number: 4801329
• Product Code: PHX
• UDI-Device Identifier: 07630040706254
• UDI-Public: 07630040706254
• 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: 2022
• Device Explanted Year: 2022
• 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): 11/11/2022

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: 06/08/2022
• Device Model Number: 04.01.0118
• Device Catalogue Number: 04.01.0118
• Device Lot Number: 173416
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2022
• 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: Female