BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 4

    MDR report key: 15259348 · Received August 19, 2022

    Report

    Report Number
    3005180920-2022-00625
    Event Type
    Injury
    Date Received
    August 19, 2022
    Date of Event
    July 25, 2022
    Report Date
    August 19, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804106
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION REVISION ALMOST 5 YEARS AFTER CEMENTLESS THA IN A 71 YEAR OLD PATIENT. ACCORDING TO REPORT, THE REVISION WAS DONE DUE TO STEM LOOSENING AND CUP MALPOSITION. THE RADIOGRAPHIC IMAGE PRE-REVISION SHOWS THE PRESENCE OF RADIOLUCENT LINE IN GRUENZONES 1 AND 7 WHILE IT IS NOT POSSIBLE TO DETERMINE IF THE POSITION OF THE CUP EVOLVED INTO SUCH POSITION. IN THE PRE-REVISION XRAY, WHICH IS AVAILABLE ONLY IN ONE PROJECTION, THE CORTICAL WALLS ARE NOT IN CLOSE CONTACT WITH THE STEM. AGAIN, WE CANNOT DETERMINE IF THIS RESULTED FROM EVOLUTION OF THE BONE DURING THE 5 YEARS OF OPERATIONAL LIFE OF THE IMPLANT OR IF IT WAS INTENTIONALLY IMPLANTED RELYING ON CANCELLOUS SUPPORT. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY CEMENTLESS HIP ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS FAILURE CANNOT BE DETERMINED. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER. LOOKING AT THE IMAGE IT IS VISIBLE THE STEM COVERED WITH PATIENT BLOOD. THE HA ON THE STEM BODY SEEMS TO BE COMPLETELY ABSORBED BY PATIENT BONE AS EXPECTED. SOME SIGNS AND SCRATCHES ARE PRESENT ON THE NECK PART DUE TO REVISION SURGERY. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF REPORTED STEM LOOSENING. BATCH REVIEW PERFORMED ON 25-JUL-2022: LOT 133064: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-OCT-2013. EXPIRATION DATE: 2018-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. OTHER COMPONENT INVOLVED: CUP: VERSAFITCUP 01.26.45.1154 ACETABULAR SHELL CC TRIO NO-HOLE Ø 54 LOT 170950: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JUN-2017. EXPIRATION DATE: 2022-06-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 4 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT WAS REVISED AND THE STEM WAS FOUND LOOSE WHILE CUP WAS MALSEATED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2791068 STEM: AMISTEM H HA COATED STD STEM SIZE 4 HIP STEM CEMENTLESS LZO MEDACTA INTERNATIONAL SA 01.18.134 133064 07630030804106

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention