BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 LM

    MDR report key: 18333706 · Received December 15, 2023

    Report

    Report Number
    3005180920-2023-00966
    Event Type
    Injury
    Date Received
    December 15, 2023
    Date of Event
    November 20, 2023
    Report Date
    December 15, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895593
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21 NOV 2023: LOT 2012098: (B)(4) MANUFACTURED AND RELEASED ON 01-FEB-2021. EXPIRATION DATE: 2026-JAN-20. 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. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER: REVISION SURGERY OF A MOTO IMPLANT AFTER 1 YEAR AND 4 MONTHS FROM PRIMARY IMPLANTATION DUE TO PAIN AND SUSPECTED TIBIAL LOOSENING. DURING REVISION SURGERY, THE TIBIAL WAS FOUND NOT LOOSENED, SO THE CAUSE OF PAIN SHOULD HAVE BEEN SOMETHING DIFFERENT. FROM THE PICTURE SENT OF THE EXPLANTED COMPONENTS, SENT FOR INVESTIGATION, IT IS NOT POSSIBILE TO NOTE ANY ANOMALIES. FROM PRELIMINARY INVESTIGATION, THERE IS NO EVIDENCE OR REASON TO SUSPECT THAT THE EVENT IS RELATED TO A FAULTY DEVICE. ADDITIONAL IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 21 NOV 2023: MOTO PARTIAL KNEE 02.18.IF3.08.LM TIBIAL INSERT FIX S3 LM - 8MM (K162084) LOT 1910080: (B)(4)MANUFACTURED AND RELEASED ON 17-DEC-2019. EXPIRATION DATE: 2024-DEC-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. MOTO PARTIAL KNEE 02.18.TF3.LM TIBIAL TRAY FIX CEMENTED S3 LM (K162084) LOT 2009937: (B)(4)MANUFACTURED AND RELEASED ON 01-FEB-2021. EXPIRATION DATE: 2026-JAN-20. 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.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ABOUT 1 YEAR AND 4 MONTHS AFTER THE PRIMARY SURGERY DUE TO PAIN AND SUSPECTED TIBIAL TRAY LOOSENING. DURING THE REVISION SURGERY, THE IMPLANTS APPEARED NOT LOOSE AND SOMETHING ELSE MUST HAVE BEEN CAUSING PAIN, BUT THE REASON REMAINS UNKNOWN.GMK-SPHERE WITH EXTENSION STEM IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042079 MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 LM KNEE FEMORAL COMPONENT HSX MEDACTA INTERNATIONAL SA 2012098 07630030895593

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention