BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L TAPER KINECTIVE FEMORAL STEM

    MDR report key: 2010518 · Received March 1, 2011

    Report

    Report Number
    1822565-2011-00467
    Event Type
    Injury
    Date Received
    March 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NO X-RAYS OR PT DEMOGRAPHICS WERE PROVIDED. SURGICAL NOTES FROM THE PRIMARY SURGERY WERE PROVIDED. THE CONDITION OF THE DEVICES IS UNK. IT IS UNK IF THE DEVICES WERE IMPLANTED WITH THE PROPER FIT AND ORIENTATION PER THE SURGICAL TECHNIQUES. IT IS ALSO UNK IF THE PT FOLLOWED THE PROPER REHABILITATION PROTOCOLS. THE PT'S MEDICAL HISTORY MAY HAVE CONTRIBUTED TO THE PAIN EXPERIENCED AFTER THE HIP REPLACEMENT. HOWEVER, A DEFINITIVE CAUSE FOR THIS ISSUE CANNOT BE DETERMINED WITH CERTAINTY BASED ON THE INFO AVAILABLE. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. 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 RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT IS EXPERIENCING PAIN FOLLOWING RIGHT TOTAL HIP ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER M/L TAPER KINECTIVE FEMORAL STEM LWJ ZIMMER, INC. 60771624

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LOT # 60825925| KINECTIVE MODULAR NECK, CATALOG # 00784802400