BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L FEMORAL STEM

    MDR report key: 3766902 · Received April 2, 2014

    Report

    Report Number
    1822565-2014-00448
    Event Type
    Injury
    Date Received
    April 2, 2014
    Date of Event
    November 21, 2013
    Report Date
    March 6, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: PRIMARY OPERATIVE NOTES WERE PROVIDED AND WERE UNREMARKABLE. REDACTED OFFICE VISIT NOTES FROM AN UNKNOWN DATE MENTION THAT EVALUATED X-RAYS SHOW THAT THE LEFT TOTAL HIP ARTHROPLASTY IS IN NORMAL ALIGNMENT WITHOUT HARDWARE FAILURE OR LOOSENING. SIX WEEK AND SIX MONTH POST OPERATIVE X-RAYS SHOW NO OBVIOUS SIGNS OF A LUCENCY AT THE DISTAL TIP OF THE FEMORAL STEM. 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. REHABILITATION PROTOCOL AND ADHERENCE THERETO ARE UNKNOWN. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 ADD'L SUBSTANTIVE INFO BE REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THERE IS LESS THAN A MILLIMETER OF LUCENCY ADJACENT TO THE DISTAL TIP OF THE FEMORAL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199993 ZIMMER M/L FEMORAL STEM LZO ZIMMER, INC. 62226014

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other