BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER

    MDR report key: 8016876 · Received October 29, 2018

    Report

    Report Number
    0002648920-2018-00763
    Event Type
    Injury
    Date Received
    October 29, 2018
    Date of Event
    December 3, 2014
    Report Date
    February 8, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    K953337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THIS REPORT IS A DUPLICATE OF 0002648920-2017-00589. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. IF ADDITIONAL INFORMATION REGARDING THIS EVENT IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED UNDER 0002648920-2017-00589.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THIS REPORT IS A DUPLICATE OF 0002648920-2017-00589. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. IF ADDITIONAL INFORMATION REGARDING THIS EVENT IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED UNDER 0002648920-2017-00589.

    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. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 00811400000, ITEM NAME: CPT 12/14 STEM SIZE 0 COCR, LOT #: 62754796, ITEM NUMBER: 3003940002, ITEM NAME: REFOBACIN BONE CEMENT R2X40G, LOT #: A411BF163R, ITEM NUMBER: RM 4901 000 3, ITEM NAME: ORTHODYNAMICS ACETABULAR SHELL, LOT #: 1403116A, ITEM NUMBER: 00801102020, ITEM NAME: ALLEN PLUG HDPE/BASO4 10C/20FL, LOT #: 62699834, ITEM NUMBER: RM 5110 000 5, ITEM NAME: ORTHODYNAMICS ACETABULAR LINER, LOT #: 1007160A. (B)(6). 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 PATIENT UNDERWENT HIP REVISION DUE TO INFECTION APPROXIMATELY ONE MONTH POST-IMPLANTATION. THE HEAD AND LINER COMPONENTS WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856477 FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 62430191

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R