MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM STD HUMERAL DIAPHYSIS - CEMENTLESS - 6; SHOULDER REVERSE SYSTEM CEMENTLESS HUMERAL DIAPHYSIS

Catalog Number	04.01.0001
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Joint Laxity (4526)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 february 2024 lot 2209910: (b)(4) items manufactured and released on 30-jun-2022.Expiration date: 2027-jun-09.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.Clinical evaluation performed by medical affairs department six months after primary rsa possibly originated by a fracture of the humerus tubercle the joint is significantly unstable the fracture is not healed and the humeral stem is loose.The situation clearly require a total revision but there is no reason to suspect a faulty device.Additional implant involved batch review performed on 27 february 2024 on reverse shoulder system 04.01.0169 glenosphere - ø36x24.5 (k170452) lot.2310548 lot 2310548: (b)(4) items manufactured and released on 01-jun-2023.Expiration date: 2028-may-14.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 6 months after the primary surgery, the joint was very unstable.The stem was not osseointegrated.The surgeon implanted a larger stem and a lateralized glenosphere for better tension and fixation of the tuberculum majus.Patient had a fracture proximal to the humerus with infection in 2022.

• Brand Name: REVERSE SHOULDER SYSTEM STD HUMERAL DIAPHYSIS - CEMENTLESS - 6
• Common Device Name: SHOULDER REVERSE SYSTEM CEMENTLESS HUMERAL DIAPHYSIS
• 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: 18985246
• Report Number: 3005180920-2024-00161
• Device Sequence Number: 8381900
• Product Code: PHX
• UDI-Device Identifier: 07630040706001
• UDI-Public: 07630040706001
• 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: 2023
• 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): 03/27/2024

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: 04.01.0001
• Device Lot Number: 2209910
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2022
• 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: Unknown