BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-T M/H RDL SOL/SHL SZ41/66

    MDR report key: 8791951 · Received July 15, 2019

    Report

    Report Number
    0001825034-2019-03036
    Event Type
    Injury
    Date Received
    July 15, 2019
    Date of Event
    August 15, 2017
    Report Date
    October 24, 2019
    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
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: M2A MOD HEAD, # ITEM 11-163673, LOT 452530; R/H IMPACT DISTAL, # ITEM 11-112116, LOT 778100; M2A-TAPER LINER, # ITEM 15-105004, LOT 060920; IMPACT METAPHYSEAL, # ITEM 112085, LOT 423090. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-03037. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND 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 THE PATIENT UNDERWENT REVISION DUE TO PAIN, DISCOMFORT, LACK OF MOBILITY AND ELEVATED METAL ION IN BLOOD APPROXIMATELY 16 YEARS POST INITIAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581619 M2A-T M/H RDL SOL/SHL SZ41/66 PROSTHESIS HIP KWY ZIMMER BIOMET, INC. N/A 099440 

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R