MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM; SHOULDER REVERSE SYSTEM HC LINER

Catalog Number	04.01.0123
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Unspecified Infection (1930); Medical device site infection (4845)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 june 2024: lot 2336602: (b)(4) items manufactured and released on 12-dec-2023.Expiration date: 2028-nov-23.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 revised.Batch review performed on 26 june 2024 on reverse shoulder system 04.01.0173.Glenosphere 39xø27 (k170452) lot.2341006.Lot 2341006: (b)(4) items manufactured and released on 29-jan-2024.Expiration date: 2029-jan-10.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
About 1 month after the primary surgery, revision was performed due to infection.No loosening of the implants and excellent stability of the bone graft in place.Glenosphere and liner revised.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM
• Common Device Name: SHOULDER REVERSE SYSTEM 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19749509
• Report Number: 3005180920-2024-00519
• Device Sequence Number: 6491415
• Product Code: PHX
• UDI-Device Identifier: 07630040706308
• UDI-Public: 07630040706308
• 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): 07/16/2024

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: 04.01.0123
• Device Lot Number: 2336602
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2023
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 77 KG