BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALACOS R 1X40 SINGLE

    MDR report key: 7779408 · Received August 13, 2018

    Report

    Report Number
    0001526350-2018-00775
    Event Type
    Death
    Date Received
    August 13, 2018
    Date of Event
    August 8, 2018
    Report Date
    October 3, 2018
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    LOD
    PMA / PMN Number
    PK030902
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF THE RECEIVING INSPECTION REPORT FOR 00111214001, LOT NUMBER 89384765, IDENTIFIED NO RELEVANT DEVIATIONS OR ANOMALIES. REVIEW OF THE RECEIVING INSPECTION REPORT FOR 00111214001, LOT NUMBER 88704749, IDENTIFIED NO RELEVANT DEVIATIONS OR ANOMALIES. HERAEUS BATCH RECORDS REVIEW INDICATES THERE WERE NO QUALITY DEVIATIONS, NO CHANGE NOTIFICATIONS, AND NO CORRECTIVE AND PREVENTIVE ACTIONS. ALL VERIFICATIONS, INSPECTIONS, AND TESTS WERE SUCCESSFULLY COMPLETED. PRODUCT EXAMINATION WAS NOT PERFORMED AS THE PRODUCT WAS NOT RETURNED FROM THE CUSTOMER. THIS COMPLAINT IS UNCONFIRMED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.

    Additional Manufacturer Narrative · 1

    THIS EVENT IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET AS IT REMAINED IMPLANTED IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY, OSS KNEE PROCEDURE ON (B)(6) 2018. THE PATIENT TOLERATED THE TIBIA CEMENTING HOWEVER; DURING INSERTION OF CEMENT IN THE FEMUR, THE PATIENT CODED. THE SURGEON CLOSED THE WOUND WITH THE TRIAL POLY REMAINING IN THE PATIENT. RESUSCITATION WAS INITIATED IN THE OR AND FOLLOWING CPR, THE PATIENT WAS TRANSFERRED TO PACU. IN PACU, AN ECHO WAS COMPLETED IN WHICH REVEALED A POSITIVE PULMONARY OR FAT EMBOLISM. IT WAS REPORTED THE PATIENT EXPIRED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618382 PALACOS R 1X40 SINGLE BONE CEMENT LOD ZIMMER SURGICAL, INC. N/A 89384765

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death