BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA S FEMORAL STEM

    MDR report key: 1970166 · Received January 14, 2011

    Report

    Report Number
    3005180920-2010-00021
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    September 7, 2010
    Report Date
    January 11, 2011
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW. QUADRA S FEM. STEM SIZE 5 - REF (B)(4)/LOT 091200. THE QUALITY AND MANUFACTURING DOCUMENTS (BATCH RECORD) WERE REVIEWED FOR THE LOT 091200 (B)(4): ALL PARAMETERS CONCERNING THE MANUFACTURING PROCESS STEPS WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. (B)(4). THE REVIEW OF THE BATCH RECORDS OF THE CORRELATED IMPLANTS WAS ALSO DONE: VERSAFITCUP DM LINER - REF (B)(4)/LOT 092368. COCR FEMORAL BALL HEAD - (B)(4)/LOT 101507. IN BOTH THE CASES ALL THE PARAMETERS WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THE EXPLANTED PIECES (STEM, BALL HEAD AND LINER) WERE RETRIEVED AND ANALYSED IN THE QUALITY CONTROL DEPARTMENT OF MEDACTA INTERNATIONAL: NO PARTICULAR FINDINGS WERE NOTICED. IT CAN HAPPEN THAT BLOOD AND DEBRIS ARE PRESENT IN THE PIN HOLE OF THE INSERT (AS INDICATED BY THE SURGEON), BUT THIS ISSUE DOES NOT HAVE ANY IMPACT ON THE IMPLANT'S FUNCTIONALITY SINCE THE HOLE DOES NOT HAVE ANY FUNCTIONAL ROLE. THE FACT IS NOT RELATED TO THE FRACTURE. (B)(4). MEDACTA INTERNATIONAL (B)(4) RATIO IS HENCE LOWER THAN THE ONE REPORTED IN LITERATURE. THERE ARE NO EVIDENCES THAT THE FRACTURE IS DEVICE RELATED BUT, FROM THE DESCRIPTION RECEIVED, IT IS LIKELY ASSOCIATED TO A FALL OR A TRAUMA.

    Description of Event or Problem · 1

    DR. (B)(6) INFORMED THAT THIS PT SUFFERED A FEMORAL FRACTURE 1 MONTH AFTER HAVING SURGERY. DR. (B)(6) HAD JUST SEEN THE PT 1 WEEK AGO AND THEY WERE FINE AND NOW ALL OF A SUDDEN SHE SUFFERED FROM A FRACTURE. DR. (B)(6) SAID THAT THE PT IS NOT COHERENT AND HE WAS NOT ABLE TO DETERMINE IF THE PT SUFFERED A FALL OR TRAUMA. DR. (B)(6) REMOVED THE SIZE 5 QUADRA STEM THAT HE HAD IMPLANTED AND BROACHED FOR A QUADRA-R. DR. (B)(6) IMPLANTED SIZE 6 QUADRA-R AFTER BROACHING TO SIZE AND THEN PUT CABLES AROUND THE FEMUR TO HEAL THE FRACTURE. WHEN REMOVING THE HEAD AND POLYETHYLENE CONSTRUCT FROM THE STEM DR. (B)(6) NOTICED THAT THE PIN HOLE ON THE BACKSIDE OF THE POLY HAD FILLED WITH BLOOD AND DEBRIS. HE THEN DECIDED THAT HE WOULD RATHER US OPEN A NEW HEAD AND LINER WHICH WE DID. DR. (B)(6) REDUCED THE HIP AND FINISHED THE CASE WITH GOOD STABILITY AND NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADRA S FEMORAL STEM FEMORAL STEM SIZE 5 STANDARD JDI MEDACTA INTERNATIONAL SA NA 091200

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention COCR FEMORAL BALL HEAD - REF (B)(4)/LOT 101507| LOT 092368| VERSAFITCUP DM LINER - REF (B)(4)