BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN M2A-MAGNUM HIP

    MDR report key: 6079001 · Received November 4, 2016

    Report

    Report Number
    0001825034-2016-04409
    Event Type
    Injury
    Date Received
    November 4, 2016
    Report Date
    October 11, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WAS NOT PROVIDED FOR THE PATIENT MENTIONED IN THE JOURNAL ARTICLE. THE ARTICLE WAS WRITTEN BY H. C. VAN DER VEEN, I. H. F. REININGA, W. P. ZIJLSTRA, M. F. BOOMSMA, S. K. BULSTRA, AND J. J. A. M. VAN RAAY.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THIS REPORT IS A DUPLICATE OF 3002806535-2015-04121.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "PSEUDOTUMOR INCIDENCE, COBALT LEVELS AND CLINICAL OUTCOME AFTER LARGE METAL-ON-METAL AND CONVENTIONAL METAL-ON POLYETHYLENE TOTAL HIP ARTHROPLASTY" WHICH AIMED TO COMPARE THE INCIDENCE OF PSEUDOTUMORS AFTER LARGE HEAD METAL-ON-METAL (MOM) TOTAL HIP ARTHROPLASTY(THA) WITH THAT AFTER CONVENTIONAL METAL-ON-POLYETHYLENE (MOP) THA, AND ALSO AIMED TO COMPARE COBALT LEVELS, FUNCTIONAL OUTCOME AND RADIOLOGICAL OUTCOME IN BOTH GROUPS TO ASSESS THEIR RELATIONSHIP TO THE TYPE OF ARTICULATION AND PSEUDOTUMOR FORMATION. A PATIENT WAS IDENTIFIED IN THE ARTICLE THAT UNDERWENT A HEMI-ARTHROPLASTY ON AN UNKNOWN DATE DUE TO ASEPTIC LOOSENING AT TWENTY-SEVEN (27) MONTHS POST-OPERATIVELY. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731358 UNKNOWN M2A-MAGNUM HIP HIP, PROSTHESIS JDI BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R