BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 36MM

    MDR report key: 16731790 · Received April 13, 2023

    Report

    Report Number
    3002806535-2023-00081
    Event Type
    Injury
    Date Received
    April 13, 2023
    Date of Event
    December 3, 2018
    Report Date
    December 20, 2023
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271397
    PMA / PMN Number
    K192683
    Removal / Correction Number
    N/A
    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 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. DEVICE IS USED FOR TREATMENT. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. PARTIAL RIGHT HIP REVISION DUE TO UNEQUAL LIMB LENGTH, CONTRIBUTING FACTORS OF EVENT: UNDERSIZED STEM. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. IT WAS REPORTED THAT THE PATIENT HEALED WELL AND AT THE 5 YEAR POST OP REVIEW, THE PATIENT REPORTED NO PAIN AND NO ISSUES. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT 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). CONCOMITANT MEDICAL PRODUCT(S) - ACETABULAR CUP, ITEM# 110017108, LOT# 3972309; ACETABULAR LINER, ITEM# 010000860, LOT# 6109006; HEAD ADAPTER, ITEM# 6501066, LOT#2920994; FEMORAL STEM ITEM# 51101170, LOT# 3661564. 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. NOT CONFIRMED.

    Description of Event or Problem · 0

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

    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 RIGHT TOTAL HIP ARTHROPLASTY PERFORMED ABOUT 5 YEARS AGO. THE PATIENT WAS REVISED 9 MONTHS LATER DUE TO AN UNDERSIZED STEM IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1479110 CER BIOLOXD OPTION HD 36MM HIP PROSTHESIS LZO BIOMET UK LTD. N/A 2904520 00887868271397

    Patients

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