BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX FORTEBALL HEAD 28 S

    MDR report key: 3689674 · Received March 6, 2014

    Report

    Report Number
    3005180920-2014-00021
    Event Type
    Injury
    Date Received
    March 6, 2014
    Report Date
    July 30, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K073337
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION HAS BEEN RECEIVED CONCERNING OUTCOMES FOR THE PATIENT NOR ABOUT THE REVISION SURGERY. THE R AND D PROJECT MANAGER MADE AN ADDITIONAL COMMENT ON THE CASE: THE CLICKING AND POPPING IS UNLIKELY TO BE ASSOCIATED WITH A DESIGN PROBLEM, IT IS PROBABLY RELATED TO EITHER A SURGICAL ERROR IN ASSESSING THE LENGTH OF THE STEM (IF TOO SHORT CAN LEAVE A GAP BETWEEN THE BALL HEAD AND THE CUP LINER AND CREATE THIS TYPE OF SOUND) OR A LAXITY OF THE MUSCLES OF THE PATIENT WHO THEREFORE IS NOT ABLE TO MAINTAIN TIGHTNESS IN THE JOINT. THE CASE WAS CLOSED WITH THE INFORMATION AVAILABLE AT THAT TIME.

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: MECTACER BIOLOX FORTE BALL HEAD SIZE 28 S: REF. (B)(4) / LOT 093031 (B)(6)): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURE. AMISTEM H CEMENTLESS FEMORAL STEM SIZE 3 LAT (B)(4): REF. (B)(4)/ LOT 102805 (B)(4): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. VERSAFITCUP DM ACETABULAR SHELL (B)(4). / LOT 102298 (B)(4): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. VERSAFITCUP DM HC UHMWPE LINER (B)(4)/ LOT 102793 (B)(4): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED. A FOLLOW UP WILL BE EVENTUALLY SUBMITTED, IN CASE OF NEW OUTCOMES.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134276 MECTACER BIOLOX FORTEBALL HEAD 28 S CERAMIC FEMORAL HEAD LZO MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1