MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø24.5X15; REVERSE SHOULDER GLENOID BASEPLATE

Catalog Number	04.01.0151
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to dissociation between the baseplate and the glenosphere at 2 years and 1 month from the primary.X-rays show upward eccentricity of the glenosphere and signs of metallosis on both the glenoid and humeral sides.Glenosphere guide was not used during the primary surgery.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager the glenosphere does not present any signs of damage, nor on the articular surface and the backsurface.This excludes that any interference with the glenoid screws occurred.The baseplate taper is massively damaged, likely due to friction with the glenosphere following implant dissociation.The glenosphere screw presents signs of damage and discoloration on the outer surfaces and the thread, compatible with friction with the glenosphere following implant dissociation.One glenoid screw (04.01.0159) does not have signs of damage, while the other one (04.01.0163) has two broken head prongs.This may have occurred during the screw removal.It was reported that the glenosphere guide was not used during the surgery.This may have caused the glenosphere malposition on the baseplate taper and subsequent mobilization.Clinical evaluation performed by medical affiars director.Revision surgery 2 years and 1 month from the primary rsa due to dissociation between the baseplate and the glenosphere.From the radiographic images the glenosphere appears rotated (eccentricity upwards) since few months after primary.According to report, metallosis is present both on the glenoid and on the humeral side, indicating repeated sliding movements between the components.Since the glenosphere guide was not used during the primary surgery, it may be possible that the glenosphere was not fully seated on the baseplate taper.For instance, the central screw may give the impression of a good tightening but the morse taper at the perimeter of the baseplate is not correctly engaged and with time the two implants may dissociate.Batch review performed on 26 jul 2024.Lot 2116432: (b)(4) items manufactured and released on 08-mar-2022.Expiration date: 2027-02-22.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Additional component involved in the event: batch review performed on 26 jul 2024 reverse shoulder system 04.01.0170 glenosphere 39xø24.5 (k170452) lot 2115425: (b)(4) items manufactured and released on 28-febr-2022.Expiration date: 2027-02-15.No anomalies found related to the problem.To date, 110 items of the same lot have been sold with another similar reported event during the period of review.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø24.5X15
• Common Device Name: REVERSE SHOULDER GLENOID BASEPLATE
• 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: 20037830
• Report Number: 3005180920-2024-00630
• Device Sequence Number: 20431927
• Product Code: PHX
• UDI-Device Identifier: 07630040706384
• UDI-Public: 07630040706384
• 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: 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): 08/22/2024

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: 04.01.0151
• Device Lot Number: 2116432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2022
• 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: 81 YR
• Patient Sex: Female