BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACOS RG 1X40 SINGLE

    MDR report key: 8348736 · Received February 18, 2019

    Report

    Report Number
    0001822565-2019-00766
    Event Type
    Injury
    Date Received
    February 18, 2019
    Date of Event
    October 18, 2018
    Report Date
    June 21, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LOD
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT IT WAS DETERMINED THAT THE ZIMMER BIOMET DOES NOT HOLD THE REPORTING RESPONSIBILITY OF THE DEVICE. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND NEEDS TO BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT IT WAS DETERMINED THAT THE ZIMMER BIOMET DOES NOT HOLD THE REPORTING RESPONSIBILITY OF THE DEVICE, THE INITIAL REPORT WAS SUBMITTED IN ERROR AND NEEDS TO BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00840002411 ULNAR COMPONENT PLASMA SPRAYED SIZE 4 115 MM LENGTH RIGHT FOR CEMENTED USE ONLY 63095903; 00840009500 ARTICULATION KIT SIZE 5/6 1 AXLE PIN, 1 HUMERAL BEARING A, 2 ULNAR BEARINGS B STERILE PRODUCT DO NOT RESTERILIZE 63785438; 211266 COMPR SRS ANTI ROT IC SEG-30MM 351820; 110029939 COMPR SRS 60MM DST HUM BDY RT 588380; 211269 COMPR SRS SMALL FLANGE 155830; 211230 COMPR SRS MOD STEM -6X75MM 36590; 00111914001 PALACOS LVG 1X40 SINGLE 87014599; 00111314001 PALACOS RG 1X40 SINGLE 89904771- QTY 1. CUSTOMER HAS INDICATED THAT THE PRODUCT WAS NOT RETURNED BY THE HOSPITAL. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2019 - 00748; 0001822565 - 2019 - 00678; 0001822565 - 2019 - 00756; 0001822565 - 2019 - 00754.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY FOR THE ELBOW AND WAS SUBSEQUENTLY REVISED FOR LOOSENING AND WOUND SITE COMPLICATION (IMPLANT BROKE THROUGH THE SKIN) TWO WEEKS POST IMPLANTATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142012 PALACOS RG 1X40 SINGLE BONE CEMENT LOD ZIMMER BIOMET, INC. 89904771

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R