MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 L

Model Number	02.07.1203L
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year 11 months after the primary, revision surgery performed due to cemented tibial tray subsidence and consequent tibial tray loosening.The surgeon revised tibial tray and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023 lot 2009470: 135 items manufactured and released on (b)(6) 2020.Expiration date: 2025-12-08.No anomalies found related to the problem.To date, 131 items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs director: 2 years after posterior-stabilized cemented tka the tibial tray is subsiding and needs replacement.We only got pre-revision xrays and therefore we cannot judge the cortical coverage of the original implant.Normally, subsidence of a cemented tray may be due to insuffiocien cortical coverage or to worsening of the bone conditions - both these situations require postoperative radiographs to be assessed.In neither case we see any reason to suspect that a faulty device caused the problem.

• Brand Name: GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 L
• Common Device Name: TIBIAL TRAY FIXED CEMENTED
• 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: 16751773
• Report Number: 3005180920-2023-00250
• Device Sequence Number: 8556138
• Product Code: JWH
• UDI-Device Identifier: 07630030819889
• UDI-Public: 07630030819889
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090988
• 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
• Report Date (Section B): 04/17/2023

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: 12/08/2025
• Device Model Number: 02.07.1203L
• Device Catalogue Number: 02.07.1203L
• Device Lot Number: 2009470
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2020
• 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 Age: 73 YR
• Patient Sex: Female
• Patient Race: Black Or African American