BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN V40 HEAD

    MDR report key: 7614459 · Received June 19, 2018

    Report

    Report Number
    0002249697-2018-01872
    Event Type
    Injury
    Date Received
    June 19, 2018
    Date of Event
    May 22, 2018
    Report Date
    October 10, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: PATIENT'S TAB. AN EVENT REGARDING CRACK/FRACTURE INVOLVING A CERAMIC HEAD WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED AS PART OF A MATERIAL ANALYSIS WHICH CONFIRMED THAT THE DEVICE WAS FRACTURED. MATERIAL ANALYSIS A MATERIAL ANALYSIS HAS BEEN PERFORMED. THE REPORT CONCLUDED: THE CERAMIC HEAD WAS FRACTURED. BASED ON THE ABOVE, THE HIGHLY STRESSED REGION OF THE CERAMIC MACHINED TAPERED SURFACE HAD UNDERGONE A PHASE TRANSFORMATION, WHICH MAY HAVE AN EFFECT ON THE STRUCTURAL INTEGRITY OF THE MATERIAL. HOWEVER, CLINICAL AND PATIENT HISTORY MAY ALSO PLAY A ROLE IN THE SURVIVORSHIP OF ANY IMPLANT. -MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW CONCLUDED; A PHASE TRANSFORMATION IN THE ZIRCONIA FEMORAL HEAD MATERIAL IN COMBINATION WITH METALLIC DEBRIS IN THE JOINT SPACE OF THE ARTHROPLASTY HAVE IN CONCERT CONTRIBUTED TO AN OVERLOAD CONDITION IN THE BEARING RESULTING IN FRACTURE OF THE CERAMIC HEAD REQUIRING REVISION SURGERY. DOES THE REVIEW IDENTIFY ANY PROCEDURAL RELATED FACTORS THAT CONTRIBUTED TO THE EVENT? - METALLIC DEBRIS IN THE JOINT SPACE OF THE ARTHROPLASTY INTRODUCED AT TIME OF IMPLANTATION. DOES THE REVIEW IDENTIFY ANY PATIENT RELATED FACTORS THAT CONTRIBUTED TO THE EVENT? - NO INFO DOES THE REVIEW IDENTIFY ANY DEVICE RELATED FACTORS THAT CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT? - A PHASE TRANSFORMATION IN THE ZIRCONIA FEMORAL HEAD MATERIAL WAS DOCUMENTED IN THE MAR. -DEVICE HISTORY REVIEW: NOT PERFORMED AS DEVICE DETAILS ARE UNKNOWN. -COMPLAINT HISTORY REVIEW: NOT PERFORMED AS DEVICE DETAILS ARE UNKNOWN. CONCLUSION: A MATERIAL ANALYSIS AND MEDICAL REVIEW BOTH CONFIRMED THAT THE DEVICE HAD FRACTURED BUT WERE UNABLE TO DETERMINE A ROOT CAUSE. ADDITIONAL INFORMATION, INCLUDING OPERATIVE REPORTS, PROGRESS NOTES, DEVICE DETAILS ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE THIS INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 0

    CERAMIC V40 HEAD BROKE. REVISION SURGERY ON (B)(6) 2018.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE UNAVAILABLE.

    Description of Event or Problem · 1

    CERAMIC V40 HEAD BROKE. REVISION SURGERY ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459781 UNKNOWN V40 HEAD UNKNOWN HIP LZO STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R