MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0120 HUMERAL REVERSE HC LINER Ø36/+3MM; SHOULDER HUMERAL REVERSE HC LINER

Model Number	04.01.0120
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed at about 6 months after primary due to joint luxation and the cause is unknown.The surgeon revised successfully the metaphysis and the liner.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023 lot 2115606: 56 items manufactured and released on (b)(6) 2022.Expiration date: 2027-01-03.No anomalies found related to the problem.To date, 47 items of the same lot have been sold with no similar reported case during the period of review.Other device involved: batch review performed on (b)(6) 2023 reverse shoulder system 04.01.0210 lat.Glenosphere 36xø27 (k193175) lot 2008830a: 62 items manufactured and released on (b)(6) 2021.Expiration date: 2026-07-01.No anomalies found related to the problem.To date, 47 items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0120 HUMERAL REVERSE HC LINER Ø36/+3MM
• Common Device Name: SHOULDER HUMERAL REVERSE HC 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: 16467482
• Report Number: 3005180920-2023-00111
• Device Sequence Number: 7737875
• Product Code: PHX
• UDI-Device Identifier: 07630040706278
• UDI-Public: 07630040706278
• Combination Product (Y/N): N
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2023

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 Model Number: 04.01.0120
• Device Catalogue Number: 04.01.0120
• Device Lot Number: 2115606
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2022
• 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: Male