BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER

    MDR report key: 8117044 · Received November 29, 2018

    Report

    Report Number
    0002648920-2018-00848
    Event Type
    Injury
    Date Received
    November 29, 2018
    Date of Event
    October 30, 2018
    Report Date
    November 29, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    K953337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. TWO X-RAYS IMAGES, ONE UNDATED AND ANOTHER DATED WERE PROVIDED. THE REVIEW STATED THAT THE RIGHT HIP ARTHROPLASTY COMPONENTS WERE ANATOMICALLY ALIGNED WITHOUT DISLOCATION. EXTENSIVE ARTIFACT WAS NOTED ON THE UNDATED IMAGE. NO OTHER ANOMALIES WERE NOTED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). ASSOCIATED PRODUCT: ALLOFIT ALLOCLASSIC SHELL WITH POLAR SCREW PLUG, PN 4245, LN 2945715. DURAL ALPHA INSERT NEUTR II/32, PN 01.00013.409, LN 2941733. AVENIR MULLER STEM 3 LATERAL, PN 01.06010.103, LN 2817021. CUSTOMER HAS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT HIP PROCEDURE, SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO INSTABILITY AND SUBLUXING APPROXIMATELY 2 MONTHS POST OP. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955950 FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 63589465

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| R