BEUDAMED
    FDA Adverse Event Other Summary report: N

    R/H MALLORY HEAD STS MODULAR CALCAR

    MDR report key: 955002 · Received April 17, 2007

    Report

    Report Number
    1825034-2007-00047
    Event Type
    Other
    Date Received
    April 17, 2007
    Date of Event
    March 6, 2007
    Report Date
    March 22, 2007
    Manufacturer
    BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    k031693
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. DIMENSIONAL INSPECTION OF THE RETURNED IMPLANT AND TRIAL COMPONENT FOUND BOTH COMPONENTS MET THE APPROPRIATE DESIGN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TOTAL HIP ARTHROPLASTY IN 2007, PHYSICIAN ENCOUNTERED FIT RELATED DIFFICULTY BETWEEN THE IMPLANT AND TRIAL COMPONENT. AS A RESULT, A 30-45 MINUTE DELAY WAS EXPERIENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 R/H MALLORY HEAD STS MODULAR CALCAR LPH LPH BIOMET, INC. NA 229710

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other