BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 28/0, TAPER 12/14

    MDR report key: 17787012 · Received September 21, 2023

    Report

    Report Number
    0009613350-2023-00523
    Event Type
    Injury
    Date Received
    September 21, 2023
    Date of Event
    August 16, 2023
    Report Date
    October 13, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    PMA / PMN Number
    K192416
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. THE DEVICE IS USED FOR TREATMENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. A SINGLE AP OVERVIEW OF THE PELVIS SHOWS DISLOCATION OF THE ACETABULAR CUP SUPERIORLY AND LIKELY POSTERIORLY. NO BONY FRACTURE IS SEEN AND NO RADIOLUCENCY. WITH THE AVAILABLE INFORMATION 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: RINGLOC BI-POLAR 28X42MM; REF#11-165208; LOT#000760. KINECTIV MODULAR NECK BB; REF#00-7848-022-01; LOT#65753444. G2- TAIWAN. 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

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 36 DAYS POST-IMPLANTATION DUE TO DISLOCATION. THE DOCTOR TRIED CLOSED REDUCTION AFTER PATIENT DISLOCATION BUT WAS UNSUCCESSFUL. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2061910 BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 28/0, TAPER 12/14 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3143928

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention| H SEE H10 NARRATIVE.