BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEUTRAL ARCOMXL LNR 32MM F

    MDR report key: 7316829 · Received March 6, 2018

    Report

    Report Number
    0001825034-2018-01462
    Event Type
    Injury
    Date Received
    March 6, 2018
    Date of Event
    December 1, 2016
    Report Date
    June 27, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE REPORTED FOR THIS EVENT. PLEASE ALSO SEE ASSOCIATED EVENTS: 0001825034 - 2018 - 01459, 0001825034 - 2018 - 01460, 0001825034 - 2018 - 01461. CONCOMITANT PRODUCT(S): A 192110 ECHO POR FMRL LAT NC 10X130MM LOT 372320; 163670 32MM MOD HEAD COCR +3MM NECK LOT 00J3639545; 010000664 G7 PPS LTD ACET SHELL 54F LOT 3671996. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTH ER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UNIQUE IDENTIFIER (UDI) # - INITIALLY REPORTED INCORRECTLY. THE UDI# IS UNKNOWN SINCE THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A PROCEDURE PERFORMED ON (B)(6) 2016, THE PATIENT REPORTED DURING A 3 MONTHS FOLLOW UP THAT SHE LIMITATIONS WITH ORDINARY WORK AND MODERATE PAIN. IT WAS ALSO REPORTED THAT PATIENT REQUIRED PAIN MEDICINE STRONGER THAN ASPIRIN. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159294 G7 NEUTRAL ARCOMXL LNR 32MM F PROSTHESIS, HIP KWZ ZIMMER BIOMET, INC. N/A 3634413

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other