BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACOS R 1X40 SINGLE

    MDR report key: 8513710 · Received April 15, 2019

    Report

    Report Number
    0001822565-2019-01318
    Event Type
    Injury
    Date Received
    April 15, 2019
    Report Date
    November 20, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LOD
    PMA / PMN Number
    K030902
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: US157250, RECAP CMT FMRL HD RESUR 50M 789720; US157856, M2A-MAGNUM PF CUP 56ODX50ID 893550; 102150, REPICCI TIBIAL 37X6.5MM 54860; 102120, REPICCI FMRL 54MM RM/LL 792370; 902929, HARPOON SIZE 2 SUTURE 775000. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, [ REMAINS IMPLANTED]. 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 FOLLOWING SURGERY PATIENT DEVELOPED A SUPERFICIAL (B)(6) WOUND INFECTION, WHICH WAS RESOLVED AFTER APPROXIMATELY 2 MONTHS OF ANTIBIOTICS. NO ADDITIONAL INFORMATION WAS MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309210 PALACOS R 1X40 SINGLE PROSTHESIS, HIP LOD ZIMMER BIOMET, INC. N/A 62253885

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R