BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/P

    MDR report key: 6502622 · Received April 18, 2017

    Report

    Report Number
    0001822565-2017-02338
    Event Type
    Injury
    Date Received
    April 18, 2017
    Date of Event
    March 17, 2017
    Report Date
    December 9, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK113296
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THE FOLLOWING SECTIONS WERE UPDATED: THESE PRODUCTS ARE USED FOR TREATMENT. NO PRODUCT WAS RETURNED, DEVICE WAS DISCARDED. THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORDS FOR WERE REVIEWED FOR DEVIATIONS AND/OR ANOMALIES WITH NO ANOMALIES/DEVIATIONS IDENTIFIED THAT ARE RELATED TO THIS EVENT. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER THE INVESTIGATION OF THIS EVENT. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, WHILE EXTRACTING WITH THE HOOKED SLAP HAMMER, THE TRIAL BROKE AT THE LEVEL OF THE HOLE INSERTION FOR THE HOOK. THE TRIAL BROKE IN HALF, WITH THE SCREW AND BOTTOM PART OF THE TRIAL REMAINING ON THE STEM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282984 ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/P PROSTHESIS, HIP LPH ZIMMER, INC. N/A 60144287

    Patients

    Seq Age Sex Outcome Treatment
    1 Other