MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+3MM; SHOULDER REVERSE HIGH-CROSS LINER

Model Number	04.01.0126
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 april 2023: lot 2240224: (b)(4) items manufactured and released on 03-jan-2023.Expiration date: 2027-12-02.No anomalies found related to the problem.To date, 7 items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs department: the patient had a primary rsa surgery on (b)(6)2023.After that time, the patient had 3 revisions due to instability and then dislocation of the joint.The patient was revised on a 4th time still due to dislocation.Therefore, the surgeon changed the reverse implant into a salvage hemiarthroplasty with an anatomical metaphysis, double eccenter, and humeral head and explanting the baseplate, screws, glenosphere, reverse metaphysis, and insert.These events are normal originated by progression of disease to the soft tissues, deformity or insufficient re-establishment of soft tissue tension after the operation.No further conclusion can be drawn with the elements at hand; however, there is no reason to suspect a malfunctioning device.Batch review performed on 27 april 2023 on reverse shoulder system 04.01.0209 lat.Glenosphere 42xø24.5 (k193175) lot.2103993 lot 2103993: (b)(4) items manufactured and released on 01-july-2021.Expiration date: 2026-06-16.No anomalies found related to the problem.To date, 5 items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
The patient had a primary shoulder surgery on (b)(6)2023.On (b)(6) 2023, the patient came in reporting instability and the cause was unknown.The surgeon revised the insert and the surgery was completed successfully.On (b)(6) 2023, the patient came reporting pain due to a dislocation of the liner from the glenosphere and the cause was unknown.The surgeon revised the liner and glenosphere and the surgery was completed successfully.On (b)(6)2023, the patient came reporting pain due to a dislocation of the liner from the glenosphere and the cause is unknown.The surgeon revised the liner, glenosphere, and metaphysis.The surgery was completed successfully.Presently, on (b)(6)2023, the patient came in due to signs of a dislocation and the cause is unknown.The surgeon performed a salvage hemiarthroplasty with an anatomical metaphysis, double eccenter, and humeral head and explanted the baseplate, screws, glenosphere, reverse metaphysis, and insert.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+3MM
• Common Device Name: SHOULDER REVERSE HIGH-CROSS 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: 16992286
• Report Number: 3005180920-2023-00359
• Device Sequence Number: 7039816
• Product Code: PHX
• UDI-Device Identifier: 07630040706339
• UDI-Public: 07630040706339
• 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: 2023
• Device Explanted Year: 2023
• 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): 05/24/2023

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: 04.01.0126
• Device Catalogue Number: 04.01.0126
• Device Lot Number: 2240224
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2023
• 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: Unknown