BEUDAMED
    FDA Adverse Event Death Summary report: N

    FEMORAL STEM CMK OC MODULAR CEMENTED

    MDR report key: 6986538 · Received October 30, 2017

    Report

    Report Number
    3006946279-2017-00201
    Event Type
    Death
    Date Received
    October 30, 2017
    Date of Event
    August 17, 2016
    Report Date
    October 30, 2017
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). CONCOMITANT PRODUCTS: CMK MOD 12/14 SZ202 L130 LOT#0001112237 ITEM#3553.202, STSTL FEM HD DIA28/ 0MM 12/14 ITEM#P0201M28 LOT#00J3731063, BIO PLUG 12.5MM LOT#913680 ITEM#163010, COBALT HV BN CMT 40GJAPAN LOT#944610 ITEM#402282J. REPORT SOURCE, FOREIGN ¿ EVENT OCCURRED IN (B)(6). COMPLAINT WAS EVALUATED, AND THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO PRODUCTS WERE RETURNED; THEREFORE, THE VISUAL AND DIMENSIONAL INSPECTION WAS NOT PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2016-03763, 0001825034-2017-08974, 3006946279-2017-00201, 3006946279-2017-00202.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED DURING A BIPOLAR HIP HEMI-ARTHROPLASTY PROCEDURE, AFTER THE PATIENT'S BLOOD PRESSURE DROPPED SUDDENLY. IT IS NOT BELIEVED THAT THE PRODUCTS CONTRIBUTED TO THE PATIENT'S DEATH, HOWEVER, CAUSE OF DEATH REMAINS UNKNOWN. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766943 FEMORAL STEM CMK OC MODULAR CEMENTED PROSTHESIS, HIP JDI BIOMET FRANCE S.A.R.L. N/A 0001112237

    Patients

    Seq Age Sex Outcome Treatment
    1 Death