BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL PRIMARY FEMORAL STEM

    MDR report key: 2092631 · Received May 10, 2011

    Report

    Report Number
    1822565-2011-01129
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    November 6, 2007
    Report Date
    April 13, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: NO DEVICES OR PHOTOS WERE AVAILABLE; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. SURGICAL NOTES WERE PROVIDED FROM THE PRIMARY SURGERY WHEN THE FRACTURE OCCURRED. PELVIC BONE QUALITY WAS DESCRIBED AS SOFT. FEMUR BONE QUALITY WAS NOT DESCRIBED. NO DETAILS REGARDING THE METHOD OF BROACHING WERE PROVIDED. IT WAS NOT DESCRIBED EXACTLY WHEN THE FRACTURE PROPAGATED, SUCH AS WHETHER IT WAS DURING BROACHING OR FINAL SEATING OF THE STEM. THE INSTRUMENTS UTILIZED WERE NOT DESCRIBED. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE FOR THE REPORTED FEMUR FRACTURE DURING THE TOTAL HIP ARTHROPLASTY CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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 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 A LONGITUDINAL CRACK WAS CREATED ON THE POSTERIOR FEMORAL NECK DURING STEM IMPLANTATION. TWO CABLES WERE PLACED TO PREVENT PROVOCATION OF THE CRACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRABECULAR METAL PRIMARY FEMORAL STEM LPH ZIMMER, INC. 60694455

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention