MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ24.5; SHOULDER REVERSE GLENOSPHERE

Model Number	04.01.0170
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager.The glenosphere shows minor scratches on the articular surface, likely due to friciton with the humeral reverse metaphysis after joint dislocation.Moreover, the taper is partially dull.The glenosphere screw has circular scratches on the head and the shaft.The outer rim of the reverse liner is damaged.This, too, may have occurred after joint dislocation, given the information at hand it is not possible to determine the root cause of the joint dislocation, nor of the loosening of the glenosphere screw.Clinical evaluation performed by medical affairs department.Revision at about 7 months after the total reverse shoulder arthroplasty due to joint luxation.The surgery was completed successfully by using another glenosphere, screw and liner.These events are normal originated by insufficient re-establishment of soft tissue tension after the operation.Given the patient humerus condition, it is probably difficult to stabilize this joint.No further conclusion can be drawn with the elements at hand.Batch review performed on (b)(6) 2023 lot 2115425: 114 items manufactured and released on (b)(6) 2022.Expiration date: 2027-02-15.No anomalies found related to the problem.To date, 92 items of the same lot have been sold with no similar reported case during the period of review.Other components involved: reverse shoulder system 04.01.0122 humeral reverse hc liner ø39/+0mm (k170452) lot 2113346: 71 items manufactured and released on (b)(6) 2021.Expiration date: 2026-11-08.No anomalies found related to the problem.To date, 68 items of the same lot have been sold with no similar reported case during the period of review.Reverse shoulder system 04.01.0151 glenoid baseplate 24,5x15 (k170452) lot 2116433: 200 items manufactured and released on (b)(6) 2022.Expiration date: 2027-04-03.No anomalies found related to the problem.To date, 189 items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
On (b)(6) 2022, the patient had a primary shoulder surgery and medacta reverse shoulder system was implanted.Presently, on (b)(6) 2023, the patient was revised due to joint luxation.During revision surgery, the surgeon noticed that the screw of the glenosphere was loose and that there was a very few fixation on the taper.The surgery was completed successfully by using another glenosphere, screw and liner.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ24.5
• Common Device Name: SHOULDER REVERSE GLENOSPHERE
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16476398
• Report Number: 3005180920-2023-00088
• Device Sequence Number: 18004118
• Product Code: PHX
• UDI-Device Identifier: 07630040706575
• UDI-Public: 07630040706575
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 03/03/2023

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: 04.01.0170
• Device Catalogue Number: 04.01.0170
• Device Lot Number: 2115425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2022
• 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: Female