BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CERAMIC FEM HD 36/-3MM

    MDR report key: 14641410 · Received June 9, 2022

    Report

    Report Number
    3002806535-2022-00270
    Event Type
    Injury
    Date Received
    June 9, 2022
    Date of Event
    April 28, 2022
    Report Date
    June 24, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271168
    PMA / PMN Number
    K192683
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL DEVICE: TPRLC 133 T1 PPS HO 17X154MM 4MM T1 ITEM#51-104170 LOT#6992243. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). UPON REVIEW OF THIS COMPLAINT FROM AN INVESTIGATION PERSPECTIVE, IT IS CONSIDERED THAT THE CERAMIC HEAD WITHIN THIS COMPLAINT DOES NOT IMPACT THE REPORTED EVENT OF PATIENT BONE FRACTURE. THE DEVICES INVOLVED IN THE REPORTED EVENT HAVE ALREADY BEEN REPORTED. SEE REPORT NUMBER 0001825034-2022-01315. GIVEN THIS INFORMATION THIS MEDWATCH WILL BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE OF THE LEFT HIP APPROXIMATELY THREE (3) DAYS POST IMPLANTATION DUE TO PERIPROSTHETIC FRACTURE AFTER A FALL TWO (2) DAYS POST IMPLANTATION. THE FRACTURE WAS SECURED WITH A PLATE AND CABLES, AND THE FEMORAL HEAD AND STEM WERE REPLACED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THISTIME.

    Description of Event or Problem · 0

    UPON REVIEW OF THIS COMPLAINT FROM AN INVESTIGATION PERSPECTIVE, IT IS CONSIDERED THAT THE CERAMIC HEAD WITHIN THIS COMPLAINT DOES NOT IMPACT THE REPORTED EVENT OF PATIENT BONE FRACTURE. THE DEVICES INVOLVED IN THE REPORTED EVENT HAVE ALREADY BEEN REPORTED. SEE REPORT NUMBER 0001825034-2022-01315. GIVEN THIS INFORMATION THIS MEDWATCH WILL BE VOIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725860 DELTA CERAMIC FEM HD 36/-3MM HIP PROTHESIS LZO BIOMET UK LTD. N/A 3096065 00887868271168

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention| H