BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD

    MDR report key: 6464343 · Received April 6, 2017

    Report

    Report Number
    0001825034-2017-02374
    Event Type
    Injury
    Date Received
    April 6, 2017
    Date of Event
    January 16, 2017
    Report Date
    February 19, 2021
    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
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PART AND LOT NUMBER ARE REQUIRED TO REVIEW DEVICE HISTORY RECORDS AND NEITHER WERE PROVIDED. PRODUCT WAS NOT RETURNED SO NO PRODUCT EVALUATION COULD BE CONDUCTED. THIS DEVICE IS USED FOR TREATMENT. UNABLE TO PERFORM A COMPATIBILITY CHECK BASED ON PROVIDED INFORMATION. COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS PART/LOT NUMBER WAS NOT PROVIDED. NO MEDICAL RECORDS RECEIVED. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. IF ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT PRODUCT - UNKNOWN STEM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-02374 & 0001825034-2017-02376.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS AND MEDICAL RECORDS, WHICH NOTED PATIENT UNDERWENT A REVISION DUE TO PSEUDOTUMOR FORMATION AND ELEVATED METAL ION LEVELS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: PART: 157444, M2A-MAGNUM MOD HD SZ 44MM, LOT: 073020. PART: US157850, M2A-MAGNUM PF CUP 50ODX44ID, LOT: 810180. PART: 139256, M2A-MAGNUM 42-50 TPR INSRT STD, LOT: 650340.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTION AND ADDITIONAL INFORMATION. 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

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL INSPECTION FOUND THE HEAD TO BE SCRATCHED AND WORN. THE HEAD REMAINS ASSEMBLED WITH A TAPER ADAPTER. THE ADAPTOR IS DINGED NEAR THE TAPER AND AROUND ONE OF THE CIRCULAR CUTOUTS. SMALL PARTICLES OF YELLOW DEBRIS WERE OBSERVED ON THE DEVICE. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY A ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED BY LEGAL COUNSEL THAT THE PATIENT ALLEGED TO MOM POST-IMPLANTATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORT FROM PATIENT'S OPERATIVE NOTES THAT DURING THE REVISION PROCEDURE THE SURGEON NOTED A VERY LARGE FLUID-FILLED PSEUDOTUMOR. FURTHER, THE PSEUDOTUMOR DESTROYED ANTERIOR THIRD TO ANTERIOR HALF OF GLUTEUS MEDIUS. THE SURGEON REMOVED AS MUCH AS POSSIBLE INCLUDING LARGE GRANULOMATOUS MASS ON THE TROCHANTER.

    Description of Event or Problem · 1

    PATIENT SUFFERED FROM PAIN, TISSUE DESTRUCTION, BONE DESTRUCTION, METAL WEAR, METAL POISONING AND LIMITATION OF DAILY ACTIVITIES.

    Description of Event or Problem · 1

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED APPROXIMATELY 6 YEARS POST IMPLANTATION DUE TO PAIN, ELEVATED METAL IONS, LOCAL TISSUE REACTION AND METAL-ON-METAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244887 M2A-MAGNUM MODULAR HEAD PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 073020

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R