BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE 5

    MDR report key: 7677473 · Received July 11, 2018

    Report

    Report Number
    3005180920-2018-00491
    Event Type
    Injury
    Date Received
    July 11, 2018
    Date of Event
    June 13, 2018
    Report Date
    July 11, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804113
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 JULY 2018; LOT 122816: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 OCTOBER 2012. EXPIRATION DATE:2017-08-31. 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. OTHER DEVICE INVOLVED: REFERENCE 01.29.209 (K112115) BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 ; LOT 115757: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 JANUARY 2012. EXPIRATION DATE: 2016-12-31. 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 ON 10 JULY 2018 BY MEDICAL AFFAIRS (B)(4): FEMORAL REVISION IN PRIMARY CEMENTLESS THA AFTER 5.5 YEARS. WE ONLY HAVE TWO PRE-REVISION RADIOGRAPHS THAT SHOW SIGNS OF PROXIMAL FEMORAL LOOSENING BUT NO OTHER CONCOMITANT CAUSE CAN BE IDENTIFIED. IT APPEARS TO BE A CASE OF ASEPTIC LOOSENING, A POSSIBLE ADVERSE EVENT FOLLOWING THA, BUT THE CAUSE CANNOT BE DETERMINED WITH THE INFORMATION AT HAND.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF THIGH PAIN 5 YEARS AFTER PRIMARY. THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD. THE CUP WAS NOT REVISED AS IT WAS WELL FIXED. THE SURGEON IMPLANTED ANOTHER COMPANY'S PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519040 AMISTEM H HA COATED STD STEM SIZE 5 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 122816 07630030804113

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention