BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BENCOX PE LINER 36/44

    MDR report key: 5744217 · Received June 23, 2016

    Report

    Report Number
    3009106092-2016-00002
    Event Type
    Injury
    Date Received
    June 23, 2016
    Date of Event
    May 20, 2016
    Report Date
    June 23, 2016
    Manufacturer
    CORENTEC CO., LTD.
    Product Code
    LPH
    UDI-DI
    08806373830372
    PMA / PMN Number
    K103431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HYPERFLEXED HIS LEFT HIP, AND THE SURGEON REDUCED THE DISLOCATION UNDER FLUOROSCOPY ON (B)(6) 2016. REVISION SURGERY WAS PERFORMED FOR CONTINUED HIP INSTABILITY ON (B)(6) 2016. IT WAS CONFIRMED THAT THE EXISTING PE LINER DID NOT DISASSOCIATE FROM THE SHELL. REPLACEMENT ELEVATED TYPE LINER AND HIGHER OFFSET FEMORAL BALL HEAD WERE IMPLANTED, AND SURGERY WAS COMPLETED AS NORMAL. DEVICE HISTORY RECORDS (DHR) OF PE LINER AND OTHER COMPONENTS WERE REVIEWED, AND DETERMINED THAT ALL WERE MANUFACTURED TO SPECIFICATION. A REVIEW OF CORENTEC`S CUSTOMER COMPLAINT HISTORY WAS UNDERTAKEN AND DID NOT IDENTIFY ANY SIMILAR EVENT, OR ANY OTHER EVENT FOR THE REPORTED LOT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND IF RECEIVED, WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD REVISION HIP SURGERY DUE TO CONTINUED HIP INSTABILITY FOLLOWING DISLOCATION, AND SUBSEQUENT REDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399615 BENCOX PE LINER 36/44 ACETABULAR PE LINER LPH CORENTEC CO., LTD. 01.02.643 11AFAB21 08806373830372

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other BENCOX HYBRID CUP (CAT NO. 01.02.064)