BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ZIMMER RASPS

    MDR report key: 2093908 · Received April 19, 2011

    Report

    Report Number
    1822565-2011-00971
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Report Date
    March 21, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    HTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RASPS NEED TO BE REPLACED AS SOON AS THEY BECOME DULL/WORN/DAMAGED. THIS CAN BE VERIFIED BY VISUALLY INSPECTING THEM OR IF THE RASP DOES NOT ADVANCE WHEN STRUCK BY MALLET. THE END OF LIFE IS NORMALLY DETERMINED BY WEAR AND DAMAGE DUE TO USE. HOWEVER, THERE IS NO OTHER SPECIFIC WAY TO DETERMINE HOW MANY SURGERIES A RASP WILL LAST BEFORE BEING REPLACED. THERE IS ALSO NO SPECIFIC METHOD TO CHECK THE SHARPNESS OTHER THAN VISUAL INSPECTION AND INTRA-OPERATIVE FEEDBACK. THIS IS TO MENTION HERE THAT LONGEVITY OF THE CUTTING EDGES DEPENDS ON HOW THE DEVICE IS USED, MAINTENANCE OF THE DEVICE, HANDLING OF THE DEVICE DURING REPROCESSING, ETC. NO DEFINITIVE CAUSE ANALYSIS CAN BE PERFORMED WITH THE INFORMATION PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON HAS HAD AN UNKNOWN NUMBER OF STEMS THAT SIT PROUD COMPARED TO THE TRIALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ZIMMER RASPS HIP INSTRUMENT HTR ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1