BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEDICACE. V40(TM) FEMORAL STEM

    MDR report key: 5358275 · Received January 11, 2016

    Report

    Report Number
    0002249697-2016-00037
    Event Type
    Malfunction
    Date Received
    January 11, 2016
    Date of Event
    December 10, 2015
    Report Date
    December 15, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DAMAGE INVOLVING A DEDICACE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION FOR THE STEM NOTED RESIDUE AT THE DISTAL END OF THE STEM. THERE WAS NO EVIDENCE OF DAMAGE OR AN 'IMPACT' TO THE DEVICE. MATERIAL ANALYSIS REPORT CONCLUDED THAT: THE INDICATION OBSERVED WAS A WHITE RESIDUE WITH EVIDENCE OF BOTH POLY(METHYL-METHACRYLATE) AND ZIRCONIUM. BOTH OF WHICH ARE KNOWN INGREDIENTS IN BONE CEMENT USED FOR FIXATION OF A PROSTHESIS TO LIVING BONE IN ORTHOPAEDIC. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. DEVICE HISTORY REVIEW: THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. IN THE EVENT IT IS STATED THAT THERE WAS AN 'IMPACT' NOTED ON THE DEVICE. THE WAS NO EVIDENCE OF DAMAGE ON THE RETURNED DEVICE, HOWEVER A RESIDE WAS NOTED ON THE DISTAL END OF THE STEM. MATERIAL ANALYSIS CONCLUDED THAT: THE INDICATION OBSERVED WAS A WHITE RESIDUE WITH EVIDENCE OF BOTH POLY(METHYL-METHACRYLATE) AND ZIRCONIUM. BOTH OF WHICH ARE KNOWN INGREDIENTS IN BONE CEMENT USED FOR FIXATION OF A PROSTHESIS TO LIVING BONE IN ORTHOPAEDIC. THE DEDICACE STEM IS INDICATED FOR CEMENTED HIP APPLICATIONS. THE SUPPLIER OF THE STEM CONFIRMED THAT THERE IS NO BONE CEMENT OR SIMILAR PRODUCTS USED IN LMO. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.

    Description of Event or Problem · 1

    THE PHARMACIST AT THE HOSPITAL RETURNED THE DEVICE TO STRYKER (B)(4) WITHOUT ANY MENTION. AFTER A PHONE CALL TO THE CONTACT PERSON, SHE REPORTED THAT "THE STEM WAS RETURNED BECAUSE IT HAD LIKE AN IMPACT ON IT. THE SURGEON DID NOT WANT TO USE IT. ANOTHER STEM WAS AVAILABLE FOR COMPLETE THE PROCEDURE WITHOUT DELAY OR ADVERSE CONSEQUENCES."

    Description of Event or Problem · 1

    THE PHARMACIST AT THE HOSPITAL RETURNED THE DEVICE TO STRYKER (B)(4) WITHOUT ANY MENTION. AFTER A PHONE CALL TO THE CONTACT PERSON, SHE REPORTED THAT "THE STEM WAS RETURNED BECAUSE IT HAD LIKE AN IMPACT ON IT. THE SURGEON DID NOT WANT TO USE IT. ANOTHER STEM WAS AVAILABLE FOR COMPLETE THE PROCEDURE WITHOUT DELAY OR ADVERSE CONSEQUENCES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16597 DEDICACE. V40(TM) FEMORAL STEM HIP IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH G5671512

    Patients

    Seq Age Sex Outcome Treatment
    1 Other