BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPACTOR

    MDR report key: 12120882 · Received July 6, 2021

    Report

    Report Number
    0001825034-2021-01908
    Event Type
    Malfunction
    Date Received
    July 6, 2021
    Date of Event
    June 22, 2021
    Report Date
    September 29, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWA
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THIS WILL BE REPORTED UNDER THE CORRECT MFR NUMBER.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THIS WILL BE REPORTED UNDER THE CORRECT MFR NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 12-151409 675270 ECHO HIP FX LAT FEMORAL 9MM, 31-323230 136730 3.2MMX30MM RNGLC+ ACET DRL BIT, 110010246 64919386 G7 OSSEOTI 4 HOLE SHELL 56MM F, 30104006 64936588 G7 VIT E NEUTRAL LNR 40MM F, 00625006525 J6871098 BONE SCR 6.5X25 SELF-TAP, 00625006525 J6831820 BONE SCR 6.5X25 SELF-TAP, 650-1058 3043515 CER BIOLOXD OPTION HD 40MM, 00785901000 64992251 DISTAL CENTRALIZER 10 MM O.D., 650-1067 3048708 CER OPTION TYPE 1 TPR SLEVE +3. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE LOCATION OF THE DEVICE IS UNKNOWN. 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 DURING SURGERY, THE INSTRUMENT FRACTURED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022074 UNKNOWN IMPACTOR INSTRUMENT, HIP HWA ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1