BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PLACOS BONE CEMENT

    MDR report key: 16929751 · Received May 15, 2023

    Report

    Report Number
    0001822565-2023-01303
    Event Type
    Injury
    Date Received
    May 15, 2023
    Date of Event
    April 3, 2023
    Report Date
    June 7, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LOD
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON FURTHER INVESTIGATION AND RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS PRODUCT BE NOT REPORTABLE AS IT WAS NOT A PRODUCT OF ZIMMER BIOMET. THE INITIAL REPORT SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCTS: ITEM#: SAGL2023, 3 PEG MONO GLEN SZ 3; LOT#: 65268598. ITEM#: 01.04555.440, HUMERAL HEAD 44-16; LOT#: 3100396. ITEM#: 01.04555.130, HUMERAL ANCHOR UNCEMENTED L; LOT#: 3112046. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 7 WEEKS POST IMPLANTATION, THE PATIENT UNDERWENT THE FIRST STAGE OF A 2-STAGE REVISION SURGERY DUE TO PAIN, SWELLING, AND INFECTION. ALL IMPLANTS WERE REMOVED, AND A SPACER WAS IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184843 UNKNOWN PLACOS BONE CEMENT BONE CEMENT/EXTREMITIES LOD ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Hospitalization| R SEE H10 NARRATIVE