BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER OPTION TYPE 1 TPR SLEVE -3

    MDR report key: 18482114 · Received January 10, 2024

    Report

    Report Number
    3002806535-2024-00016
    Event Type
    Injury
    Date Received
    January 10, 2024
    Date of Event
    March 14, 2023
    Report Date
    February 12, 2024
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00880304521940
    PMA / PMN Number
    K200959
    Adverse Event
    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 PRODUCTS REMAIN IMPLANTED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. DEVICES ARE USED FOR TREATMENT. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW IDENTIFIED NORMAL ROM, LEG LENGTHS WERE EQUAL, ANTERIOR RIGHT HIP PAIN AD INFLAMMATION WITH FLEXION AND INTERNAL /EXTERNAL ROTATION. SURGEON DISCUSSED OPTION OF DOWNSIZING CUP. 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 BIOLOXD OPTION HD 36MM; ITEM# 650-1057; LOT# 537390. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2024-00015. 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 BEGAN TO EXPERIENCE MODERATE PAIN WITH A DECREASE IN RANGE OF MOTION APPROXIMATELY 6 YEARS POST-IMPLANTATION. THE PATIENT RECEIVED CORTISONE INJECTIONS FOR RIGHT INGUINAL PAIN, EXACERBATED WITH ACTIVE HIP FLEXION. THE CORTISONE INJECTIONS ALLEVIATED THE PAIN FOR THREE WEEKS BUT IS NOW REPORTING SEVERE PAIN. NO DEFINITIVE PLANNED INTERVENTION HAS BEEN REPORTED. 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
    2550063 CER OPTION TYPE 1 TPR SLEVE -3 HIP PROSTHESIS LZO BIOMET UK LTD. 329700 00880304521940

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R