BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APR HIP COLLARLESS FEMORAL STEM

    MDR report key: 2130591 · Received June 14, 2011

    Report

    Report Number
    1822565-2011-01359
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    January 28, 2010
    Report Date
    May 19, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS REC'D FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: THE DEVICE WAS IMPLANTED IN (B)(6) 2008 AND THEN EXPLANTED IN (B)(6) 2010, AN IN VIVO TIME OF APPROX 20 MONTHS. THE DEVICE WAS NOT RETURNED FOR REVIEW, SO ITS CONDITION IS UNK. SURGICAL NOTES FROM WHEN THE DEVICE WAS IMPLANTED DID NOT INDICATE ANY COMPLICATIONS. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNK. THERE IS INSUFFICIENT INFORMATION TO PERFORM A PROBABLE CAUSE ANALYSIS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION: THE MANUFACTURING RECORDS OF THE STEM WERE REVIEWED FOUND TO BE CONFORMING INDICATING THAT THE STEM WAS MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT PRESENTED WITH PAIN AND WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APR HIP COLLARLESS FEMORAL STEM LPH ZIMMER, INC. 60530146

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention