BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE PLUS TMZF HIP STEM #4

    MDR report key: 4123349 · Received September 26, 2014

    Report

    Report Number
    0002249697-2014-03667
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY REVIEW INDICATE THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW. THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED STERILE LOT. THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED AS PATIENT INFORMATION, CLINICAL HISTORY, AND RESULTS OF BLOODWORK FOR INFECTION WERE NOT PROVIDED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT IS A RECURRENT DISLOCATOR HAVING DISLOCATED ABOUT 6 TIMES. ORIGINAL SURGERY WAS DONE IN 2011 IN WHICH AN ACCOLADE TMZF #4, 36MM + 5 LFIT V40 HEAD, TRIDENT HEMISPHERICAL 64MM, AND A TRIDENT X3 POLY LINER WERE IMPLANTED. PT BROUGHT BACK INTO THEATRE (B)(6) 2014. WHEN THE SURGEON OPENED UP THE PATIENT, THE TISSUE WAS ALL INFECTED. ONCE HE REMOVED THE HEAD FROM THE TRUNNION THERE WAS BLACK TAR LIKE SUBSTANCE AROUND THE TRUNNION & OPENING TO THE HEAD. THE X3 POLY WAS YELLOW AND THERE WAS POLY WEAR, ALSO A RING OF PLASTIC WAS FOUND INSIDE THE PATIENT (IT LOOKED LIKE THE RING OF PLASTIC HAD COME OFF THE POLY CUP). DR THINKS THE CUP WAS OXIDISED. HE REMOVED THE FEMORAL HEAD AND X3 LINER AND REPLACED WITH A TRIDENT CONSTRAINED INSERT AND 32MM FEMORAL HEAD. I HAVE COLLECTED THE DAMAGED POLY LINER AND RING OF PLASTIC AND SENT TO STRYKER (B)(4).

    Description of Event or Problem · 1

    PATIENT IS A RECURRENT DISLOCATOR HAVING DISLOCATED ABOUT 6 TIMES. ORIGINAL SURGERY WAS DONE IN 2011 IN WHICH AN ACCOLADE TMZF #4, 36MM + 5 LFIT V40 HEAD, TRIDENT HEMISPHERICAL 64MM, AND A TRIDENT X3 POLY LINER WERE IMPLANTED. PT BROUGHT BACK INTO THEATRE (B)(6) 2014. WHEN THE SURGEON OPENED UP THE PATIENT, THE TISSUE WAS ALL INFECTED. ONCE HE REMOVED THE HEAD FROM THE TRUNNION THERE WAS BLACK TAR LIKE SUBSTANCE AROUND THE TRUNNION & OPENING TO THE HEAD. THE X3 POLY WAS YELLOW AND THERE WAS POLY WEAR, ALSO A RING OF PLASTIC WAS FOUND INSIDE THE PATIENT (IT LOOKED LIKE THE RING OF PLASTIC HAD COME OFF THE POLY CUP). DR THINKS THE CUP WAS OXIDISED. HE REMOVED THE FEMORAL HEAD AND X3 LINER AND REPLACED WITH A TRIDENT CONSTRAINED INSERT AND 32MM FEMORAL HEAD. I HAVE COLLECTED THE DAMAGED POLY LINER AND RING OF PLASTIC AND SENT TO STRYKER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602895 ACCOLADE PLUS TMZF HIP STEM #4 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 34915301

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention