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

Catalog Number	04.01.0170
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on 18 july 2024: lot 2217135: (b)(4) items manufactured and released on 21-sep-2022.Expiration date: 2027-09-04.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 involved, batch reviews performed on 18 july 2024: reverse shoulder system 04.01.0151 glenoid baseplate ø24.5x15 (k170452) lot 2209626: (b)(4) items manufactured and released on 09-sep-2022.Expiration date: 2027-08-25.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 manager: revision surgery 1 year and 4 months after primary rsa due to disengagement of the glenosphere from the baseplate.From the radiographic images it is not possible to retrieve any information regarding the position of the implants but it may be possible that the glenosphere was not correctly aligned and fixed during the primary surgery.For instance, if the guide had not been used properly, the central screw may have given the impression of a good tightening but the morse taper at the perimeter of the baseplate may not have been correctly engaged potentially leading to the issue reported.Investigation performed by r&d shoulder manager based on the pictures received: the glenosphere is confirmed to be dissociated from the baseplate with the screw out of its intended position.The x-rays do not allow to confirm it was correctly aligned and fixed after the primary surgery.No sign of damage is visible on the glenosphere in the provided pictures.The dissocation does not appear to be related to interference with the polyaxial screws.The central screw presents discoloration on the outer surface and the thread is damaged.This is likely caused by friction with the baseplate central bore following screw loosening.
Event or Problem Description
During a control visit it was found that the glenosphere was disengaged from the baseplate.Revision surgery was performed at about 1 year and 4 months post-primary.All devices were revised successfully.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ24.5
• Common Device Name: SHOULDER 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19918233
• Report Number: 3005180920-2024-00623
• Device Sequence Number: 8095105
• Product Code: PHX
• UDI-Device Identifier: 07630040706575
• UDI-Public: 07630040706575
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/06/2024

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: 04.01.0170
• Device Lot Number: 2217135
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2024
• Initial Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2022
• 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 Age: 79 YR
• Patient Sex: Female