BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CERAMIC FEM HD 36/0MM

    MDR report key: 14641533 · Received June 9, 2022

    Report

    Report Number
    3002806535-2022-00271
    Event Type
    Injury
    Date Received
    June 9, 2022
    Date of Event
    May 10, 2022
    Report Date
    June 8, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271175
    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 PRODUCTS: TLOC 133 MP SP T1 PPS HO 7X99 ITEM#51-109070 LOT#3652988. G7 PPS LTD ACET SHELL 52E ITEM#010000663 LOT#7061616. 36MM I.D. SIZE E NEUTRAL LINER ITEM#30103605 LOT#65256574. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE OF THE RIGHT HIP APPROXIMATELY ONE MONTH POST IMPLANTATION DUE TO SUBSIDENCE OF THE FEMORAL STEM AFTER LIMB LENGTH DISCREPANCY WAS NOTED. DURING REVISION, A CRACK IN THE UPPER FEMORAL SHAFT AND THE GREATER TROCHANTER DEVELOPED. THESE WERE REPAIRED AND THE FINAL COMPONENTS WERE REPLACED WITHOUT FURTHER COMPLICATION. 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
    2449639 DELTA CERAMIC FEM HD 36/0MM HIP PROTHESIS LZO BIOMET UK LTD. N/A 3095543 00887868271175

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Hospitalization| R