BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM M2A MOD HEAD +3MM NK

    MDR report key: 6944634 · Received October 12, 2017

    Report

    Report Number
    0001825034-2017-08073
    Event Type
    Injury
    Date Received
    October 12, 2017
    Date of Event
    September 11, 2017
    Report Date
    December 15, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    PK003363
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD 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. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. CONCOMITANT MEDICAL PRODUCTS: 15-105004, M2A-TAPER LINER SZ 41/32, 704920; 10-104058, M2A-T M/H RAD 2HL SHL 41/58 MM, 628060; 162315, BI-METRIC POROUS FMRL 17X165 MM, 090460. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-08438, 0001825034-2017-08439.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO AN ALLERGIC REACTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726234 32MM M2A MOD HEAD +3MM NK PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A 059910

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R