BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHO POR FMRL RED NC 12X140MM

    MDR report key: 8096760 · Received November 21, 2018

    Report

    Report Number
    0001825034-2018-10832
    Event Type
    Injury
    Date Received
    November 21, 2018
    Date of Event
    August 8, 2018
    Report Date
    November 21, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K070274
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: M2A MAGNUM CUP, CATALOG #: US157850, LOT #: 011000. M2A MAGNUM HEAD, CATALOG #: 157444, LOT #: 368540. ECHO FEMORAL, CATALOG #: 192412, LOT #: 262570. REPORTED EVENT WAS CONFIRMED BY REVIEW OF REVISION OPERATIVE NOTES RECEIVED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED WITH NO DEVIATIONS IDENTIFIED. A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. MULTIPLE MDR REPORTS WERE FILED; PLEASE SEE ASSOCIATED REPORTS: 0001822565-2018-06557, 0001825034-2018-08306. 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. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 8 YEARS POST IMPLANTATION DUE TO PAIN AND ELEVATED ION LEVELS. FURTHER, THERE WAS MALPOSITIONING AND BONE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934676 ECHO POR FMRL RED NC 12X140MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 262570

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R