BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7IN CAE 16.5 MMA

    MDR report key: 3363097 · Received September 23, 2013

    Report

    Report Number
    1818910-2013-28208
    Event Type
    Injury
    Date Received
    September 23, 2013
    Date of Event
    October 1, 2010
    Report Date
    September 9, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORD AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. PER THE INITIAL REPORTING BY THE DEPUY CLINICAL TEAM, NO ADDITIONAL INFORMATION IS AVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THAT, AT A FOLLOWUP VISIT 14.1 YEARS AFTER A PRIMARY THA, PATIENT REPORTED SEVERAL FALLS. THE FIRST OCCURRED APPROXIMATELY A YEAR AND A HALF PRIOR TO THIS VISIT WHEN SHE TRIPPED OVER THE TRACK WHILE WALKING OUT HER SLIDING GLASS DOOR. ALTHOUGH SHE INITIALLY NEEDED A WALKER AFTER THE FALL, SHE NOW AMBULATES WITHOUT PAIN AND ONLY USES A CANE OUTSIDE HER HOME. XRAYS REVEALED A FEMUR FRACTURE WITH HEALED CALLUS AND A BROKEN BUT STABLE STEM. PATIENT WAS ADVISED OF INCREASED RISK OF FURTHER FRACTURE AND IMPLANT FAILURE. CONTINUED OBSERVATION WAS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478855 7IN CAE 16.5 MMA FEMORAL HIP STEM LPH 1818910 DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention