MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+0MM; SHOULDER LINER

Catalog Number	04.01.0125
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	03/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 april 2024: lot 2308781: (b)(4) items manufactured and released on 14-aug-2023.Expiration date: 2028-jul-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional implant involved, batch review performed on 10 april 2024: reverse shoulder system 04.01.0174 glenosphere 42x27 (k170452) lot 2311735: (b)(4) items manufactured and released on 27-sep-2023.Expiration date: 2028-sep-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
Revision surgery performed about 1 month after the primary surgery due to infection.Glenosphere and liner revised.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+0MM
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19228066
• Report Number: 3005180920-2024-00268
• Device Sequence Number: 17863026
• Product Code: PHX
• UDI-Device Identifier: 07630040706322
• UDI-Public: 07630040706322
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2024

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 Catalogue Number: 04.01.0125
• Device Lot Number: 2308781
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2023
• 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 Age: 74 YR
• Patient Sex: Male