BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO II TAPER INSERT STD 0MM T

    MDR report key: 13840391 · Received March 21, 2022

    Report

    Report Number
    0001825034-2022-00638
    Event Type
    Injury
    Date Received
    March 21, 2022
    Date of Event
    February 28, 2022
    Report Date
    March 21, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWL
    UDI-DI
    00880304228351
    PMA / PMN Number
    K984028
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG#: 12-139030 ENDO II MOD ENDO HEAD SZ 53 LOT#: 492360, CATALOG#: 110010247 G7 OSSEOTI 4 HOLE SHELL 58MM G LOT#: 6819555, CATALOG#: 110024465 G7 DUAL MOBILITY LINER 46MM G LOT#: 371300, CATALOG#: 00625006525 BONE SCR 6.5X25 SELF-TAP LOT#: 64984806, CATALOG#: 00625006525 BONE SCR 6.5X25 SELF-TAP LOT#: J6917785, CATALOG#: 00625006530 BONE SCR 6.5X30 SELF-TAP LOT#: J7126858, CATALOG#: 00625006525 BONE SCR 6.5X25 SELF-TAP LOT#: J6864830, CATALOG#: 650-1055 CER BIOLOXD OPTION HD 28MM LOT#: 3087401, CATALOG#: 650-1068 CER OPTION TYPE 1 TPR SLEVE +6 LOT#: 3063684, CATALOG#: 110031013 VIVACIT-E DM BEARING 28X46MM LOT#: 64912250, CATALOG#: 163665 28MM DIA COCR MOD HD +9MM NK LOT#: 64998701. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE WAS REQUESTED BUT NOT RETURNED BY THE HOSPITAL; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. 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: 0001825034-2022-00639.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE FOR A CONVERSION OF A HEMI HIP TO A TOTAL HIP ARTHROPLASTY DUE TO PROGRESSION OF DEGENERATIVE JOINT DISEASE (DJD). 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
    19839 ENDO II TAPER INSERT STD 0MM T PROSTHESIS, HIP KWL ZIMMER BIOMET, INC. N/A 160270 00880304228351

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R SEE H10 NARRATIVE