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

Catalog Number	04.01.0151
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Primary surgery performed in 2020.Revision surgery was performed due to pain.Signs of extensive metallosis and significant bone loss were found during revision.The glenoid component was found to be mobilized.The surgeon removed the prosthesis and put a temporary cement spacer to let the bone heal.
Additional Manufacturer Narrative
Batch review performed on 19 december 2023 lot 2006579: (b)(4) items manufactured and released on 18-nov-2020.Expiration date: 2025-oct-27.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 component involved, batch review performed on 19 december 2023 reverse shoulder system 04.01.0170 glenosphere 39xø24.5 (k170452) lot.2003386 lot 2003386: (b)(4) items manufactured and released on 10-sep-2020.Expiration date: 2025-aug-30.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.Reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot.Unknown.
Event or Problem Description
Primary surgery was performed in 2021.Patient was doing ok until a fall in (b)(6) 2023.Xrays were taken on (b)(6) 2023 and the surgeon noticed superior offset of glenosphere.On (b)(6) 2023, the patient was operated and a temporary spacer was placed.Signs of extensive metallosis and significant bone loss were found.Also, the glenoid and glenosphere were loose and the polyaxial screws were broken.On (b)(6) 2024, permanent implants were placed.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department: revision surgery 2 years and 11 months after the primary rsa.From the radiographic images pre-op primary , it is visible that the surgery was done due to a fracture.Then, almost 2 years after the primary the patient had a fall.Radiographies were taken 3 months after the fall and the patient was then reoperated 11 months after the fall.From the radiographic image taken 3 months after the fall it is visible that the screws are broken and there are some osteolitic areas in the central peg sympthoms of mobilization.On (b)(6) 2023, the patient was re-operated and a temporary spacer was placed because signs of extensive metallosis were present.The metallosis was probably due to the movements between the baseplate and the glenosphere.This may have been caused by the traumatic event which loosened the fixation between the two components and caused fracture of the bone screws.Therefore, significant bone loss was found.It is planned to insert a new implant.The reason of the failure of the implant is due to the fall which caused the screw breakage and the mobilization of the glenosphere.On (b)(6) 2024, we received the x-rays, and from the analysis, we concluded instead that the root cause of the event can be identified in the traumatic event experienced by the patient.Other devices involved: batch review performed on 8 january 2024.Lot 2001156: (b)(4) items manufactured and released on 13-may-2020.Expiration date: 2025-may-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.Lot 2008488: (b)(4) items manufactured and released on 03-nov-2020.Expiration date: 2025-oct-15.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.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø24.5X15
• Common Device Name: 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: 18370935
• Report Number: 3005180920-2023-01030
• Device Sequence Number: 7767570
• 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: 2021
• 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,Followup
• Report Date (Section B): 02/02/2024

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 Expiration Date: 10/27/2025
• Device Catalogue Number: 04.01.0151
• Device Lot Number: 2006579
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2020
• 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