BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE 4

    MDR report key: 7380659 · Received March 29, 2018

    Report

    Report Number
    3005180920-2018-00187
    Event Type
    Injury
    Date Received
    March 29, 2018
    Date of Event
    February 27, 2018
    Report Date
    March 29, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804106
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 29 MARCH 2018; LOT 135429: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 FEBRUARY 2014. EXPIRATION DATE: 31.DEC.2018; NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø58 REFERENCE 01.26.45.0058 (K103352); LOT 141682: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 MAY 2014. EXPIRATION DATE: 30.APRIL.2019; TO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. HCT FLAT PE HC LINER Ø 36 / F REFERENCE 01.26.3648 (K103352); LOT 144775: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 OCTOBER 2014. EXPIRATION DATE: 31.AUGUST.2019; NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MANUFACTURER OF THE BALL HEAD (PIECE NOT MARKETED IN US) ON THE 13RD MARCH 2018 SEND US THE DOCUMENT REVIEW: THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULLFIL THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT OR NON-CONFORMITIES REGARDING STERILISATION. DUE TO A LACK OF CERAMIC PARTS FURTHER INVESTIGATIONS CANNOT BE DONE. PRELIMINARY INVESTIGATION PERFORMED BY R&D PRODUCT MANAGER ON 27 MARCH 2018: FROM THE IMAGES ANALYSIS, THE IMPLANT DOES NOT SHOW ANY PARTICULAR SIGN OF DAMAGE. HYDROXYAPATITE ON BOTH ACETABULAR CUP AND FEMORAL STEM SEEMS TOTALLY ABSORBED. NO SIGNS OF MOBILIZATION FROM X-RAY ANALYSIS. INFECTION IS A WELL-KNOWN POSSIBLE COMPLICATION OF JOINT REPLACEMENT AND FROM THE DATA ANALYSIS, THERE IS NO EVIDENCE THAT THE EVENT IS DEVICE RELATED. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON 23 MARCH 2018: LATE INFECTION IN CEMENTLESS THA, 3 YEARS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES.

    Description of Event or Problem · 1

    REVISION AFTER ABOUT 3 YEARS AND 3 MONTHS FOR HIP INFECTION (STREPTOCOCCUS URALIS). THE IMPLANTS HAVE BEEN EXPLANTED AND A CEMENT SPACER WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224588 AMISTEM H HA COATED STD STEM SIZE 4 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 135429 07630030804106

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention