BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC E1 HIP BRG 28X42MM

    MDR report key: 7088216 · Received December 6, 2017

    Report

    Report Number
    0001825034-2017-10968
    Event Type
    Injury
    Date Received
    December 6, 2017
    Date of Event
    November 17, 2017
    Report Date
    December 6, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK161190
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: 110024463 G7 DUAL MOBILITY LINER 42MM E, LOT: 590370. 010001001 G7 SCREW 6.5MM X 40MM LOT #: 6033599. 010000663 G7 PPS LTD ACET SHELL 52E LOT #: 6057951. 010000999 G7 SCREW 6.5MM X 30MM LOT #: 6120428. 010001000 G7 SCREW 6.5MM X 35MM LOT #: 3823755. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN THE ASSOCIATED RISK DOCUMENTATION. THESE DEVICES WERE USED WITH A DEPUY HEAD AND STEM ZIMMER-BIOMET HAS NOT ASSESSED OR CONFIRMED THE COMPATIBILITY OF THIS COMBINATION OF DEVICES, AND THIS WOULD BE CONSIDERED AN OFF-LABEL USE OF THESE DEVICES. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866454 ACT ARTIC E1 HIP BRG 28X42MM HIP PROSTHESIS LPH ZIMMER BIOMET, INC. N/A 305760

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R SEE H10