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

Model Number	04.01.0170
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20-dec-2024.Lot 1904876: (b)(4) items manufactured and released on 04-oct-2019.Expiration date: 2024-09-23.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation: revision 4 years and 6 months after primary rsa, due to glenosphere dissociated from the baseplate.From the post-primary radiograph, the glenosphere seems not fully coupled with the baseplate.Therefore, this may have led to the dissociation of the two parts.Moreover, according to report, metallosis was found during revision surgery indicating a probable relative movement between baseplate and glenosphere.Additional implant involved; batch review performed on 20-dec-2024.Reverse shoulder system 04.01.0151 glenoid baseplate - ø24.5x15 (k170452) lot 1908235: (b)(4) items manufactured and released on 26-feb-2020.Expiration date: 2025-02-16.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
At about 4 years and 6 months after primary, the patient came in reporting pain and from the performed x-rays it has been noticed that the glenosphere dissociated from the baseplate and glenosphere screw unscrewed.On the post-primary radiographs, a slight gap can be seen between the tip of the glenoid screw and the baseplate peg.Moreover, metallosis was found during revision surgery.A new glenosphere, glenosphere screw and inlay have been successfully implanted.
Additional Manufacturer Narrative
Visual inspection performed by medacta r&d shoulder project manager: the glenosphere articular surface does not report any major signs of wear but only two minor scratches in the superoposterior portion of the articular surface.The taper interface displays only minor signs of wear, although in the inferoposterior quadrant a major scratch is present.In correspondance of that sign, the laser marked medacta logo looks partially worn out, whereas the othjer laser marked texts in the backsurface are not worn out.This may be caused by a contact with the glenosphere backsurface with a not well implanted glenoid polyaxial locking screw.Indeed, if a polyaxial screw is not well inserted into the baseplate, the screw head will be a bit proud with respect to its own seat, thus leading to a contact with the abcksurface of the glenosphere.The glenosphere screw torx interface does not show any sign of usage or wear.Its threaded portion does not display any sign of wear.The central portion (not threaded) looks majorly worn out with a central visibile scratch.The screw head looks worn out.Based on the information available no definitive root cause can be established, although it is likely that the glenosphere was not fully coupled with the baseplate, contributing to the dissociation and to the metallosis due to a possible movement between the implants.There is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: GLENOIDSPHERE 39XØ24.5
• 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: 21165846
• Report Number: 3005180920-2024-01132
• Device Sequence Number: 9429605
• Product Code: PHX
• UDI-Device Identifier: 07630040706575
• UDI-Public: 07630040706575
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2025

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 Expiration Date: 09/23/2024
• Device Model Number: 04.01.0170
• Device Lot Number: 1904876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2019
• 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