BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V40 COCR LFIT HEAD 36MM/+5

    MDR report key: 4123347 · Received September 26, 2014

    Report

    Report Number
    0002249697-2014-03668
    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
    JDI
    PMA / PMN Number
    K022077
    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 DISLOCATION AND INFECTION INVOLVING A V40 COCR HEAD WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: THE REPORTED DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT ID OR STERILE LOT ID. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED AS FURTHER INFORMATION SUCH AS PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    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 SOUTH PACIFIC HEAD OFFICE.

    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) HEAD OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602516 V40 COCR LFIT HEAD 36MM/+5 IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH MJPVM3

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention