BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 36MM

    MDR report key: 18482206 · Received January 10, 2024

    Report

    Report Number
    3002806535-2024-00017
    Event Type
    Injury
    Date Received
    January 10, 2024
    Date of Event
    November 23, 2019
    Report Date
    February 9, 2024
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00880304521957
    PMA / PMN Number
    K200959
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. THE PRODUCT REMAINS IMPLANTED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. DEVICE IS USED FOR TREATMENT. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW IDENTIFIED DISLOCATION OF RIGHT HIP DUE TO FALL. SUCCESSFUL REDUCTION OF DISLOCATION UNDER MODERATE SEDATION. PATIENT WAS BENDING OVER AND FELT HER HIP POP CAUSING HER TO FALL. PATIENT REPORTS A HISTORY OF HIP DISLOCATIONS THAT SHE IS TYPICALLY ABLE TO POP BACK INTO PLACE BY STANDING UP. RIGHT HIP TENDERNESS, DEFORMITY, SHORTENED AND EXTERNALLY ROTATED. THE MEDICAL RECORDS STATE THAT THE X-RAY SHOWS DISLOCATED RIGHT THA, NO EVIDENCE OF FRACTURE, LEFT HIP IS ALIGNED. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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 - ASSOCIATED MEDICAL DEVICES: CER OPTION TYPE 1 TPR SLEVE -3; ITEM#: 650-1065; LOT#: 329700. TPRLC 133 TYPE1 PPS SO 9X137MM; ITEM#: 51-103090, LOT#: 3880920. G7 FINNED 3 HOLE SHELL 52E; ITEM#: 110017103; LOT#: 3841407. G7 NEUTRAL E1 LINER 36MM E; ITEM#: 010000857; LOT#: 3915013. 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 EXPERIENCED A DISLOCATION APPROXIMATELY 3 YEARS AFTER THE INITIAL IMPLANTATION DUE TO A FALL. THE HIP WAS SUCCESSFULLY REDUCED WITH MODERATE SEDATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141984 CER BIOLOXD OPTION HD 36MM HIP PROSTHESIS LZO BIOMET UK LTD. 537390 00880304521957

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R