BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM-H PROX. COAT. STD STEM SIZE 4

    MDR report key: 8840207 · Received July 30, 2019

    Report

    Report Number
    3005180920-2019-00628
    Event Type
    Injury
    Date Received
    July 30, 2019
    Date of Event
    July 3, 2019
    Report Date
    July 30, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804397
    PMA / PMN Number
    K161635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 10 JULY 2019: LOT 182815: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JULY-2018. EXPIRATION DATE: 2023-06-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT ADDITIONAL DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 10 JULY 2019: CUP: VERSAFITCUP CC TRIO 01.26.45.1158 ACETABULAR SHELL CC TRIO NO-HOLE Ø 58 (K122911) LOT 181710: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAY-2018. EXPIRATION DATE: 2023-05-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. PRELIMINARY INVESTIGATION PERFORMED BY MEDACTA R&D HIP PROJECT MANAGER: FROM THE RECEIVED IMAGES, NO PARTICULAR SIGNS WERE NOTICED THAT COULD RELATE TO THE EVENT. ANALYZING THE X-RAY IMAGES, ACCORDINGLY TO THE MEDICAL DIRECTION, THE POSITIONING OF THE STEM AND THE CUP, PROTRUDING FROM THE RELATED SEATS, COULD BE A CAUSE RELATED TO THE EVENT; FROM THE RECEIVED INFORMATION THE EVENT CANNOT BE RELATED TO A DEFECTIVE DEVICE. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: FEW MONTHS AFTER PRIMARY CEMENTLESS THA A REVISION IS REQUIRED FOR LOOSENING. THE ANATOMY OF THE PATIENT PROBABLY DROVE THE FEMORAL RESECTION LEVEL TO BE EXTREMELY LOW AND IN THESE CONDITIONS THE STEM IS SUBJECT TO AN EXTREME CHALLENGE TO WITHSTAND ROTATIONAL LOADS. PROBABLY FOR THE SAME REASON, AND TO PRESERVE CORRECT LEG LENGTH, THE CUP HAS BEEN IMPLANTED TOO PROUD FROM THE ACETABULUM AND COULD NOT OFFER SUFFICIENT STABILITY. THE CAUSE FOR THIS REVISION IS NOT DEFECTIVE DEVICES.

    Description of Event or Problem · 1

    ON THE (B)(4) 2019 WE WERE INFORMED OF A REVISION SURGERY PERFORMED ON THE (B)(6) 2019, ABOUT 4 MONTHS AND A HALF FROM THE PRIMARY FOR STEM LOOSENING AND CUP MALPOSITIONING. FEMUR STRESS SHIELDING WAS DETECTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635991 STEM: AMISTEM-H PROX. COAT. STD STEM SIZE 4 UNCEMENTED HIP STEM LZO MEDACTA INTERNATIONAL SA 182815 07630030804397

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention