BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-POLY LINER

    MDR report key: 7324363 · Received March 8, 2018

    Report

    Report Number
    0001825034-2018-01748
    Event Type
    Injury
    Date Received
    March 8, 2018
    Report Date
    March 27, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK090103
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION PM156506 NAME: CRUZ RT TRIFLANGE 58X25 LOT: 048900; S061140 NAME: SELEX/MAGNUM MOD HD 40MM -6 LOT: 484060 UNKNOWN STEM; 31-323240 NAME: 3.2MMX40MM RNGLC+ ACET DRL BIT LOT: 014690; 405883 NAME: COMP RVS 3.2MM DRL LOT: 342680; 405883 NAME: COMP RVS 3.2MM DRL LOT: 432120; 103535 NAME: TI LOW PROFILE SCREW 6.5X40MM LOT: 841550; 103533 NAME: TI LOW PROFILE SCREW 6.5X30MM LOT: 841520; 103531 NAME: TI LOW PROFILE SCREW 6.5X20MM LOT: 841440; 103530 NAME: TI LOW PROFILE SCREW 6.5X15MM LOT: 618640; 103530 NAME: TI LOW PROFILE SCREW 6.5X15MM LOT: 863870; 103532 NAME: TI LOW PROFILE SCREW 6.5X25MM LOT: 647820; CP161942 NAME: TI LOCK-SCR CANCLS 6.5X25MM LOT: 596050; CP161941 NAME: TI LOCK-SCR CANCLS 6.5X20MM LOT: 596020; CP161941 NAME: TI LOCK-SCR CANCLS 6.5X20MM LOT: 322680; CP161943 NAME: TI LOCK-SCR CANCLS 6.5X30MM LOT: 596060; CP161942 NAME: TI LOCK-SCR CANCLS 6.5X25MM LOT: 893860; CP161940 NAME: TI LOCK-SCR CANCLS 6.5X15MM LOT: 048530. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MEDICAL DEVICES: ITEM NUMBER: S061140, ITEM NAME: MAGNUM HEAD, LOT #: 484060, ITEM NUMBER: UNKNOWN, ITEM NAME: UNKNOWN STEM, LOT #: UNKNOWN, ITEM NUMBER: PM156506, ITEM NAME: TRIFLANGE CUP, LOT NUMBER: 048900, ITEM NUMBER: 31-323240, ITEM NAME: RINGLOC DRILL BIT, LOT #: 014690, ITEM NUMBER: 405883, ITEM NAME: DRILL, LOT #: 342680, ITEM NUMBER: 405883, ITEM NAME: DRILL, LOT #: 432120. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 01747, 0001825034 - 2018 - 01593 , 0001825034 - 2018 - 01749.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT HAS BEEN INDICATED FOR HIP REVISION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167735 E-POLY LINER PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 558190

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SEE H10