BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M/L TAPER SIZE 9.0 EXTENDED OFFSET

    MDR report key: 7044529 · Received November 20, 2017

    Report

    Report Number
    0001822565-2017-07833
    Event Type
    Injury
    Date Received
    November 20, 2017
    Date of Event
    May 6, 2013
    Report Date
    December 11, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PK032726
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00-8751-011-36, HXPE LINER NEUT 54 JJ X 36, 62146568, 00-8775-036-01, BIOLOX DELTA HD 12/14 36X-3.5, 2678794, 00-8752-011-36, HXPE LINER ELEVATED JJ 36, UNKNOWN, 00-8757-054-01, CONTINUUM TM SHELL CLUST 54 JJ, UNKNOWN, 00-6250-065-30, TRILOGY BONE SCREW 6.5X30, 62292634, 00-8751-011-36, HXPE LINER NEUT 54 JJ X 36, 62146568. CUSTOMER HAS BEEN INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 THAT THE PATIENT'S LEFT HIP WAS REVISED APPROXIMATELY ONE MONTH POST IMPLANTATION DUE TO STEM SUBSIDING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823509 M/L TAPER SIZE 9.0 EXTENDED OFFSET PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 61548738

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R