BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBALT HV BONE CEMENT 40G

    MDR report key: 11702131 · Received April 21, 2021

    Report

    Report Number
    0001825034-2021-01145
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    August 10, 2016
    Report Date
    August 31, 2021
    Manufacturer
    .
    Product Code
    LOD
    PMA / PMN Number
    K402282
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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). 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. CONCOMITANT MEDICAL PRODUCTS: PART # 141225, BIOMET CC I-BEAM TRAY, LOT #: J2870452. PART #: 183660, VNGD PS TIB BRG, LOT #: 131230. PART #: 183132, VAN PS OPEN INTL FEM, LOT #: 970450. PART #: 184788, SERIES A PAT THIN, LOT #: 025010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP REVISION SURGERY 3 YEARS POST IMPLANTATION DUE TO INSTABILITY WITH TIBIAL COMPONENT LOOSENING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600931 COBALT HV BONE CEMENT 40G BONE CEMENET LOD . NI 787570

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10