MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0191 THREADED GLENOID BASEPLATE Ø24.5X30; REVERSE SHOULDER THREADED GLENOID BASEPLATE

Model Number 04.01.0191

Device Problem Material Separation (1562)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/13/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 19 april 2022: lot 183704: (b)(4) items manufactured and released on 10-sept-2018.Expiration date: 2023-08-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event.Visual inspection performed by r&d manager: the taper of the glenoid baseplate is damaged in an eccentric fashion, likely due to repetitive rotation of the glenosphere following dissociation.The concave lateral surface, too, is worn out (the markings are not visible).One peripheral hole was destroyed by the surgeon using a high speed burr to allow for the removal of the glenoid screw.No bone residuals are visible on the baseplate back-surface.The glenosphere has circular markings on the convex back-surface likely due to the friction with at least one protruding screw.With the information at hand it is not possible to determine whether the screw was not fully seated or backed out after time.The taper is partially dull.The typical grey-colored anodization is no more visible on the glenosphere screw, except for the top surface.The thread is worn.The cause of these is recognized as wear following glenosphere dissociation and subsequent friction of the screw with the surrounding implants.Glenoid screws: l14 mm: no signs of damage.L18 mm: the top surface of the four winglets is massively worn out, likely due to friction with the glenosphere convex back-surface.L30 mm: no signs of damage.L30 mm: as given in the event description, the screw head was removed during the revision case to allow to withdraw the screw.Bone residuals are attached on one side of the thread.The opposite side is damaged in such a way that suggests that the screw was removed using a trephine reamer.The outer rim of the humeral reverse liner is massively worn out.The position of the scratches and the shape of the damage suggest that the liner was damaged due to friction with the scapula or other bony structures following glenosphere dissociation.The humeral reverse metaphysis is provided assembled with the humeral short diaphysis.Bone residuals are present on the proximal region of the diaphysis, while none is visible on the reverse metaphysis.The medial border of the reverse metaphysis is worn due to friction with the glenosphere following implant dissociation.Clinical evaluation performed by medical affairs director: at about 3 years after primary rsa the glenosphere disassociates from the baseplate and reintervention is required.The images show some circular marks on the backside of the glenosphere suggesting that one or more of the baseplate fixation screws may have backed out or not have been fully seated at index surgery, preventing proper seating of the glenosphere on the taper spigot.Future patient outcome may of course be threatened by the possibility that an infection developed; the suspect of this being the case made the surgeon place a spacer and delay reimplantation of a prosthetic device.Other device involved: batch review performed on 19 april 2022: reverse shoulder system 04.01.0170 glenosphere 39xø24.5 (k170452) lot 174731: (b)(4) items manufactured and released on 26-oct-2017.Expiration date: 2022-09-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 2018.

Event Description

Revision surgery at 3 years and 2 months post primary due to dissociation of the glenosphere from the baseplate.All devices revised successfully.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0191 THREADED GLENOID BASEPLATE Ø24.5X30
• Type of Device: REVERSE SHOULDER THREADED GLENOID BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14317038
• MDR Text Key: 291202457
• Report Number: 3005180920-2022-00341
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040715478
• UDI-Public: 07630040715478
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/06/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2023
• Device Model Number: 04.01.0191
• Device Catalogue Number: 04.01.0191
• Device Lot Number: 183704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2022
• Initial Date Manufacturer Received: 04/07/2022
• Initial Date FDA Received: 05/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention