BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM M2A HI CARBON HD -6MM NK

    MDR report key: 7898061 · Received September 21, 2018

    Report

    Report Number
    0001825034-2018-08904
    Event Type
    Injury
    Date Received
    September 21, 2018
    Date of Event
    June 20, 2017
    Report Date
    December 13, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    K003363
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: PN:15-105044, M2A TPR HI CARBON 41/32MM LNR LN: 075190, PN X11-180308, BI-METRIC/X POR NC LAT 8X120, LN 013230, PN 10-111154, C2A-T M/H RAD 2HL SHL 41/54MM, LN 555190. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES 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). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN CUP, PN UNKNOWN, LN UNKNOWN.MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS:0001825034-2018-08905.CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION (RETAINED BY HOSPITAL). 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 PATIENT RECEIVED THE FIRST TOTAL HIP ARTHROPLASTY APPROXIMATELY 10 YEARS PRIOR TO THE REVISION SURGERY WHICH WAS DUE TO PAIN, SEVERE OSTEOLYSIS, LARGER PSEUDOTUMOR, SEVERELY ELEVATED COBALT AND CHROMIUM LEVELS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739731 32MM M2A HI CARBON HD -6MM NK PROSTHESIS HIP KWY ZIMMER BIOMET, INC. NI 080690

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R