BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 1

    MDR report key: 8137103 · Received December 6, 2018

    Report

    Report Number
    3005180920-2018-00970
    Event Type
    Injury
    Date Received
    December 6, 2018
    Date of Event
    November 9, 2018
    Report Date
    December 6, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804076
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 04 DECEMBER 2018: LOT: 157485: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 APR 2016. EXPIRATION DATE: 2021-04-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL COMPONENT INVOLVED: BATCH REVIEW PERFORMED ON 06 DECEMBER 2018: BALL HEADS: BIPOLAR HEAD 25060.2848 BIPOLAR HEAD Ø28X48, LOT: 160502: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 APR 2016. EXPIRATION DATE: 2021-04-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: HIP REVISION OCCURRED 2 YEARS AFTER CEMENTLESS BIPOLAR HEMIARTHROPLASTY IN AN ELDERLY WOMAN. RADIOLUCENT LINES ARE VISIBLE IN GRUEN ZONE 1 AND STEM LOOKS SLIGHTLY UNDERSIZED. THE REASON OF THIS CHOICE MAY BE DUE TO PARTICULAR PATIENT ANATOMY THAT CANNOT BE ASSESSED NOT HAVING PREOPERATIVE IMAGES. THE REASON OF THIS FAILURE CANNOT BE DETERMINED. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: FROM THE VISUAL INVESTIGATION, WEAR OF THE ARTICULATING SURFACE OF THE FEMORAL HEAD IS VISIBLE. EXTRACTION MARKS ARE VISIBLE ON THE EQUATORIAL REGION AND ON THE FEMORAL NECK. FEMORAL HEAD SHOWS NOTCH PROBABLY DUE TO EXTRACTION AT THE BOTTOM OF THE TAPER CAVITY. HYDROXYAPATITE LAYER HAS BEEN ABSORBED DURING IN SITU TIME.

    Description of Event or Problem · 1

    ON NOVEMBER 7, 2018 WE WERE INFORMED ABOUT A REVISION PLANNED FOR CHONDROLYSE OF THE CUP AND LOOSENING OF THE STEM 2 YEARS AFTER PRIMARY. THE SURGEON OPERATED THE PATIENT ON (B)(6) 2018: HE REMOVED THE COCR BALL HEAD, THE BIPOLAR HEAD AND THE STEM, IMPLANTING AN APRICOT CEMENTED CUP (SIZE 48, REF : 20570.3248HC; LOT 149014), A QUADRA-C STEM (SIZE 1 STD : REF : 01.12.041; LOT 170211) WITH MECTAPLUG SIZE 10 MM (REF: 01.33.002; LOT 7717131) AND MECTACER FEMORAL HEAD (32 MM XL OFFSET +7, REF : 01.29.207; LOT 172262).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977094 STEM: AMISTEM H HA COATED STD STEM SIZE 1 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 157485 07630030804076

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention