BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA, CERAMIC FEMORAL HEAD¸ 36/0, TAPER 12/14

    MDR report key: 15741849 · Received November 7, 2022

    Report

    Report Number
    0009613350-2022-00565
    Event Type
    Injury
    Date Received
    November 7, 2022
    Date of Event
    October 5, 2019
    Report Date
    December 12, 2022
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    K192416
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS:11010268 BIOMET G7 OSSEOTI ACETABULAR SHELL 60MM LOT#UNK. G7 NEU +5MM E1 LINER 36MM G LOT UNKNOWN SERIAL UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE REMAINS IMPLANTED; 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION . TRILOGY BONE SCR 6.5X30 ITEM # 00-6250-065-30, LOT#UNK, TRILOGY BONE SCR 6.5X30 ITEM # 00-6250-065-20, LOT#UNK, POR TAPER FEM ST 14X135MM # 00-7862-014-00, LOT# 61402789. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED: PRODUCT EVALUATION COULD NOT BE PERFORMED. DEVICE USED FOR TREATMENT. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED, THEREFORE NO REVIEW COULD BE PERFORMED. MEDICAL RECORDS WERE REVIEWED AND DID NOT YIELD ANY FURTHER INFORMATION RELEVANT TO THE INVESTIGATION. WITH THE AVAILABLE DATA A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAD A LEFT HIP REVISION SURGERY DUE TO METAL RELATED PATHOLOGY AND APPROXIMATELY 1 (ONE) MONTH LATER, THE PATIENT WAS TREATED IN THE EMERGENCY DEPARTMENT FOR A LEFT HIP SUPERIOR DISLOCATION. THE HIP WAS REDUCED UNDER SEDATION WITHOUT ISSUE AND GOOD ALIGNMENT WAS ACHIEVED. THE PATIENT WAS PLACED IN AN IMMOBILIZER AND ADVISED TO FOLLOW-UP WITH HER ORTHOPEDIST. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    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
    2829224 BIOLOX DELTA, CERAMIC FEMORAL HEAD¸ 36/0, TAPER 12/14 PROSTHESIS, HIP LZO ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE H10 NARRATIVE| SEE H10 NARRATIVE