BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 12/14 32MM +9

    MDR report key: 9008452 · Received September 12, 2019

    Report

    Report Number
    1818910-2019-104142
    Event Type
    Injury
    Date Received
    September 12, 2019
    Date of Event
    August 20, 2019
    Report Date
    August 21, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    UDI-DI
    10603295033455
    PMA / PMN Number
    K031803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). THIS IS A DUPLICATE REPORT OF 1818910-2019-102855. 1818910-2019-104142 IS BEING RETRACTED AS IT IS A REPORT DUPLICATION. 1818910-2019-102855 WILL BE KEPT FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019 VIA THA. IT WAS REPORTED THAT THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2019 BY EXPLANTING THE STEM (P/N: L20310), THE HEAD (P/N: 136532330) DUE TO POSTOPERATIVE INFECTION. THE SURGERY WAS COMPLETED WITHIN A 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810020 DELTA CER HEAD 12/14 32MM +9 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS LZO DEPUY ORTHOPAEDICS INC US 8918054 10603295033455

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention