BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN M2A HIP

    MDR report key: 5873505 · Received August 12, 2016

    Report

    Report Number
    0001825034-2016-03087
    Event Type
    Injury
    Date Received
    August 12, 2016
    Report Date
    October 21, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY A. V. LOMBARDI JR, K. R. BEREND, M. J. MORRIS, J. B. ADAMS, AND M. A. SNELLER. MANUFACTURE DATE ¿ NI. (B)(4). THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 4 STATES, ¿LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY.¿ NUMBER 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." NUMBER 10 STATES, "FRETTING AND CREVICE CORROSION MAY OCCUR AT INTERFACES BETWEEN COMPONENTS." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." DEVICE LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "SHOULARGE-DIAMETER METAL-ON-METAL TOTAL HIP ARTHROPLASTY: DISLOCATION INFREQUENT BUT SURVIVORSHIP POOR" WHICH AIMED TO DETERMINE AT A MINIMUM OF 2 YEARS¿ FOLLOWUP (1) THE PROPORTION OF PATIENTS WHO EXPERIENCED A DISLOCATION; (2) THE SHORT-TERM SURVIVORSHIP OBTAINED WITH THESE IMPLANTS; (3) THE CAUSES OF FAILURE AND THE PROPORTION OF PATIENTS WHO DEVELOPED AN ADVERSE REACTION TO METAL DEBRIS; AND (4) WHETHER THERE WERE ANY IDENTIFIABLE RISK FACTORS FOR REVISION. APPROX 47 PATIENTS WERE REVISED DUE TO AN ADVERSE REACTION TO METAL DEBRIS, ELEVATED METAL ION LEVELS, PSEUDOTUMOR FORMATION, AND/OR SOFT TISSUE DAMAGE. OF THE 47 PATIENTS, CORROSION AT THE NECK/HEAD JUNCTION WAS PRESENT IN 18 PATIENTS AND A PSEUDOTUMOR WAS NOTED IN 22 OF THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523486 UNKNOWN M2A HIP PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R