BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABGII NO4 CEMENTLESS LEFT V40

    MDR report key: 4100090 · Received September 18, 2014

    Report

    Report Number
    0002249697-2014-03552
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MAY
    PMA / PMN Number
    K110807
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PERIPROSTHETIC FRACTURE AFTER A FALL INVOLVING AN ABGII NO4 CEMENTLESS LEFT V40 WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION AND RESULTS. THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION INDICATED THAT INSUFFICIENT MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW INDICATED THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW. THE COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO SIMILAR PREVIOUSLY REPORTED EVENTS FOR THE SAME LOT NUMBER THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THE REPORTED EVENT COULD NOT BE CONFIRMED BASED ON THE INFORMATION PROVIDED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LEFT THA ON (B)(6) 2014. THE PATIENT WAS INTOXICATED AND FELL, THAT CAUSED A PERI PROSTHETIC FRACTURE AROUND THE FEMORAL STEM. THE PATIENT WAS BROUGHT TO SURGERY TO REMOVE STEM AND REPLACE WITH BIOMET ACROSS REVISION STEM. BACK INSERTS FOR TRITANIUM CUP WERE BROUGHT IN AND SINCE THERE WAS NO DAMAGE TO THE POLYETHELYNE, THE DOCTOR OPTED NOT TO REPLACE IT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LEFT THA ON (B)(6) 2014. THE PATIENT WAS INTOXICATED AND FELL, THAT CAUSED A PERI PROSTHETIC FRACTURE AROUND THE FEMORAL STEM. THE PATIENT WAS BROUGHT TO SURGERY TO REMOVE STEM AND REPLACE WITH BIOMET ACROSS REVISION STEM. BACK INSERTS FOR TRITANIUM CUP WERE BROUGHT IN AND SINCE THERE WAS NO DAMAGE TO THE POLYETHELYNE, THE DOCTOR OPTED NOT TO REPLACE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578381 ABGII NO4 CEMENTLESS LEFT V40 IMPLANT MAY STRYKER ORTHOPAEDICS-MAHWAH G4024482A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R