BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L TAPER FEMORAL STEM

    MDR report key: 3242950 · Received July 19, 2013

    Report

    Report Number
    1822565-2013-01125
    Event Type
    Injury
    Date Received
    July 19, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEPARATE OFFICE VISIT INFORMATION FROM (B)(6) 2013, SHOW THAT THE LUCENCIES HAD NOT PROGRESSED IN SIZE DURING THAT TIME PERIOD. PRIMARY OPERATIVE NOTES WERE PROVIDED WHICH WERE UNREMARKABLE, HOWEVER, THEY WERE NOT SPECIFICALLY DETAILED. IN GENERAL, PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE: AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY. SPECIFIC REHABILITATION PROTOCOL AND ADHERENCE THERETO IS UNKNOWN. X-RAYS HAVE BEEN REVIEWED. COMPARING THE 6 WEEK X-RAYS TO THE 12 MONTH X-RAYS, IT IS APPARENT THAT A MINIMAL RADIOLUCENT LINE HAS APPEARED, MOST APPARENTLY IN ZONE 1. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION: 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 INVESTIGATION, 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 X-RAYS SHOW RADIOLUCENCY AROUND THE FEMORAL STEM, HOWEVER, PATIENT IS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337994 ZIMMER M/L TAPER FEMORAL STEM LPH ZIMMER, INC. 61647146

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other