BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, ø 36/+3.5, TAPER 12/14

    MDR report key: 21731459 · Received March 31, 2025

    Report

    Report Number
    0009613350-2025-00203
    Event Type
    Injury
    Date Received
    March 31, 2025
    Date of Event
    January 29, 2025
    Report Date
    April 24, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024430372
    PMA / PMN Number
    K192416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM # 0100561217, WAGNER CONE PROSTHESIS®, 125°, UNCEMENTED, ø 17, TAPER 12/14, LOT # 3148141. ITEM # 110010244, G7 OSSEOTI 3 HOLE SHELL 52MM E, LOT # 7480872. ITEM # 010000935, G7 HI-WALL E1 LINER 36MM E, LOT # 6923381. ITEM # 31-323230, 3.2MMX30MM RNGLC+ ACET DRL BIT, LOT # 65976365. G2: REPORT SOURCE AUSTRALIA. 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). NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATIONS. MEDICAL RECORDS WERE NOT PROVIDED. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CANNOT BE CONFIRMED AND A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT HIP REVISION POST IMPLANTATION DUE TO UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171471 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, ø 36/+3.5, TAPER 12/14 PROSTHESIS, HIP LZO ZIMMER GMBH 3136761 00889024430372

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Female Hospitalization| R SEE H11 NARRATIVE