BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 2007139 · Received February 25, 2011

    Report

    Report Number
    3005180920-2011-00008
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    October 19, 2010
    Report Date
    February 25, 2011
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS INITIALLY REPORTED AS A REVISION OF A CERAMIC HEAD, THAT IS NOT MARKETED IN THE USA AND, FOR THIS REASON, THE COMPLAINT WAS NOT REPORTED. DURING A REVIEW OF OUR CASES AND AFTER A FOLLOW-UP WITH OUR BRANCH IN (B)(6), WE NOTICED THAT A STEM MARKETED IN THE USA WAS ALSO INVOLVED AND, FOR THIS REASON, NOW WE ARE REPORTING THE CASE. THE DOCUMENTED REVIEW OF THE EXPLANTED CERAMIC BALL HEAD HAS BEEN PERFORMED BY CERAMTEC, THE QUALITY DOCUMENTS SHOW THAT THE VALUES OBTAINED ON THE COMPLAINED PART WERE ACCORDING TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. THE MANUFACTURING DOCUMENTS (BATCH RECORD) OF THE HA COATED STEM WERE ALSO REVIEWED: ALL THE VALUES WERE FOUND TO BE CONFORMING TO SPECIFICATIONS IN FORCE AT TIME OF PRODUCTION; LOT 092770 COMPRISES (B)(4) RELEASED ON THE MARKET IN (B)(6) 2010. (B)(4). ANALYSIS: THE CERAMIC BALL HEAD WAS NOT RETRIEVED, THE ANALYSIS OF THE PIECE IS NOT NECESSARY SINCE THE FEMUR FRACTURE IS NOT RELATED TO THE CERAMIC BALL HEAD. THE AMISTEM WAS NOT EXPLANTED: NO ANALYSIS CAN BE DONE. DURING PRIMARY SURGERY, THE PER OPERATIVE NOTCHING AT THE BASE OF THE GREATER TROCHANTER WAS RECORDED AS ADVERSE EVENT IN CFRS PT. THE PHYSICIAN DECIDED NOT TO MODIFY THE RECOVERY OF THE PT, THE PT WAS NORMALLY DISCHARGED 6 DAYS AFTER PRIMARY SURGERY. THE NOTCHING AT THE BASE OF THE GREATER TROCHANTER, WHICH OCCURRED DURING PRIMARY SURGERY, PROBABLY WEAKENED THE FEMUR AND WHEN THE PT WAS DISCHARGED 6 DAYS AFTER THE SURGERY, THE FEMUR WAS STRESSED AND FRACTURED. THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    THE PT HAD A POST TROCHANTERIC AVULSION DURING THE POST OPERATIVE PERIOD. POST OP XRAY DID NOT SHOW ANY FRACTURE. THE FRACTURE ONLY SHOWED UP IN THE 6 WEEK REVIEW. A REVISION SURGERY WAS PERFORMED: IT WAS CHANGED ONLY THE CERAMIC BALL HEAD (UNBROKEN) AND FIXED THE FRACTURE; THE STEM WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMISTEM H FEMORAL STEM FEMORAL STEM SIZE 4 STANDARD LZO MEDACTA INTERNATIONAL SA 092770

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention CERAMIC BALL HEAD: REF. (B)(4)| MARKETED IN THE USA.| LOT. 623499 MFG BY CERAMTEC (B)(4) AND NOT