BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALUMINA C-TAPER HEAD 32MM/-2.5

    MDR report key: 3781379 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01578
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K003391
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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 WEAR INVOLVING A CERAMIC HEAD FOLLOWING A REPORTED TRAUMA WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: A MATERIAL ANALYSIS HAS BEEN PERFORMED. THE REPORT CONCLUDED: WEAR SCARS ON THE RETURNED CERAMIC HEAD AND CERAMIC INSERT WERE OBSERVED AND WERE CONSISTENT WITH IN-VIVO USE. MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW: REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: REVIEW INDICATED THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. IT IS NOTED THAT THE PATIENT SUFFERED A TRAUMA BEFORE THE REPORTED EVENT. ADDITIONAL INFORMATION, INCLUDING OPERATIVE REPORTS, PROGRESS NOTES, AND X-RAYS ARE NEEDED TO FULLY INVESTIGATE THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF THE RIGHT HIP DUE TO GRINDING SENSATION FOLLOWING TRAUMA. INTRA-OPERATIVELY FOUND WEAR ON THE CERAMIC AND CERAMIC BEARING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF THE RIGHT HIP DUE TO GRINDING SENSATION FOLLOWING TRAUMA. INTRA-OPERATIVELY FOUND WEAR ON THE CERAMIC AND CERAMIC BEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260820 ALUMINA C-TAPER HEAD 32MM/-2.5 IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH 14223601

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| O| R