BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM M2A MOD HEAD +3MM NK

    MDR report key: 6857501 · Received September 12, 2017

    Report

    Report Number
    0001825034-2017-07013
    Event Type
    Injury
    Date Received
    September 12, 2017
    Date of Event
    February 5, 2004
    Report Date
    January 24, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDL
    PMA / PMN Number
    PK042841
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, (STILL IMPLANTED). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT PRODUCTS: MODULAR HEAD COMPONENT P/N 163674 L/N 570550; COLLARLESS BI-METRIC POROUS STEM; P/N X11-180313 L/N 340400. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2017-07013, 0001825034-2017-07014.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MODEL #: UNKNOWN. MANUFACTURE DATE: UNKNOWN. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: BI-METRIC/X POR NC LAT 14X150 CAT: X11-180314 LOT: 166690, M2A-T UNIV 2-HOLE SHL SZ 41/54 CAT: 15-103684 LOT: 923020, M2A-TAPER LINER SZ 41/32 CAT: 15-105004 LOT: 876740. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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 POST IMPLANTATION, PATIENT¿S LEFT LEG IS FIVE CENTIMETERS SHORTER THAN THE RIGHT LEG. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637129 32MM M2A MOD HEAD +3MM NK PROSTHESIS, HIP JDL ZIMMER BIOMET, INC. N/A 180950

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other SEE H10