MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM

Model Number	04.01.0122
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 november 2024: lot 2245564: (b)(4) items manufactured and released on 13-apr-2023.Expiration date: 2028-03-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.
Event or Problem Description
At about 3 months after the primary the patient came in reporting instability.The surgeon revised the 39 / +0 liner with a 39 / +6 liner and the surgery was completed successfully.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM
• 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: 20900784
• Report Number: 3005180920-2024-01057
• Device Sequence Number: 5004709
• Product Code: PHX
• UDI-Device Identifier: 07630040706292
• UDI-Public: 07630040706292
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2024

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 Model Number: 04.01.0122
• Device Lot Number: 2245564
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2023
• 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