BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD -3MM NK

    MDR report key: 7348626 · Received March 19, 2018

    Report

    Report Number
    0001825034-2018-01728
    Event Type
    Injury
    Date Received
    March 19, 2018
    Report Date
    June 27, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DATE OF EVENT - UNKNOWN DATE IN (B)(6) 2015. EXPLANT DATE - UNKNOWN DATE IN (B)(6) 2015. CONCOMITANT MEDICAL PRODUCTS: 15-106056, M2A-38 CUP NON FLARED SZ 56 MM, 952330. THE 103207, TAPERLOC POR FMRL 13.5X147, 109310. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-01727, 0001825034-2018-01729.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT HIP REVISION APPROXIMATELY FOUR YEARS POST-IMPLANTATION DUE TO PAIN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192132 M2A 38MM MOD HD -3MM NK PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 603760

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R