BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L TAPER FEMORAL STEM

    MDR report key: 5441866 · Received February 17, 2016

    Report

    Report Number
    1822565-2016-00315
    Event Type
    Injury
    Date Received
    February 17, 2016
    Date of Event
    January 25, 2016
    Report Date
    January 12, 2017
    Manufacturer
    ZIMMER INC
    Product Code
    LZO
    PMA / PMN Number
    PK063251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. UPDATED 510(K): K063251. NO DEVICE WAS RETURNED; THE PHOTOGRAPH OF THE EXPLANTED DEVICES ARE INTACT AND DO NOT SHOW SIGNS OF SIGNIFICANT WEAR. DHR REVIEW SHOWS NO DEVIATIONS OR ANOMALIES IN THE MANUFACTURING PROCESS. THE REPORTED DEVICES ARE USED FOR TREATMENT. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO ADDITIONAL COMPLAINTS FOR THE PART AND LOT COMBINATION. IT WAS CONFIRMED THAT THE DEVICE WAS USED IN AN APPROVED AND COMPATIBLE COMBINATION. RETURNED OPERATIVE NOTES STATE THAT THE ORIGINAL HIP IMPLANT SURGERY WAS PERFORMED WITHOUT COMPLICATION. PATIENT IS STATED TO HAVE A HIGH ACTIVITY LEVEL. ADHERENCE TO REHABILITATION PROTOCOL IS NOT KNOWN. PATIENT IS STATED TO HAVE EXCELLENT BONE QUALITY. X-RAYS WERE REVIEWED DURING A FOLLOW UP VISIT, AND A PERIPROSTHETIC PROXIMAL FEMUR FRACTURE WAS NOTED THAT HAS LED TO IMPLANT LOOSENING. THERE IS ALSO A SMALL PIECE OF BONE AROUND THE TIBIAL TUBERCLE. PATIENT FELL ON THEIR RIGHT KNEE, AND THEIR HEALTHCARE PROFESSIONAL STATES THEY SUFFERED A PATELLA TENDON TEAR. THEY DID NOT COMPLAINT OF PAIN IN THE HIP, HOWEVER PAIN WAS STATED TO BE SEVERE WITH RANGE OF MOTION. WITH THE INFORMATION PRESENTED, THE ROOT CAUSE FOR THE REPORTED PERIPROSTHETIC FRACTURE IS DUE TO PATIENT INJURY FROM FALLING.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT FELL AND BROKE HIS FEMUR AFTER A TOTAL HIP REPLACEMENT THAT WAS PERFORMED ON (B)(6) 2015. THE STEM WAS LOOSE AND NEEDED TO BE REPLACED TO A LONG STEM THAT WOULD PROVIDE DISTAL FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98738 ZIMMER M/L TAPER FEMORAL STEM LZO LZO ZIMMER INC 62560137

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention