BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER OPTION TYPE 1 TPR SLEVE +6

    MDR report key: 20544931 · Received October 28, 2024

    Report

    Report Number
    3002806535-2024-00408
    Event Type
    Injury
    Date Received
    October 28, 2024
    Date of Event
    October 2, 2024
    Report Date
    November 7, 2024
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271502
    PMA / PMN Number
    K192683
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): D10: ITEM # 650-1057, CER BIOLOXD OPTION HD 36MM, LOT # 3062925. ITEM # XL-156233, ARCOMXL 36MM RLC LNR +5MM SZ23, LOT # 65781860. ITEM # UNKNOW, UNKNOWN RINGLOC SHELL. LOT # UNKNOWN. ITEM # 00-7053-058-20, FULL BLADEG 58MM, LOT # UNKNOWN. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: G3; H2; H3; H6; H10 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 THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATIONS. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CANNOT BE CONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT HIP REVISION FOR UNKNOWN REASONS; THE SURGEON EXPLANTED FEMORAL HEAD AND ACETABULAR COMPONENTS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AT THIS TIME

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167815 CER OPTION TYPE 1 TPR SLEVE +6 PROSTHESIS, HIP LZO BIOMET UK LTD. N/A 3137180 00887868271502

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H11 NARRATIVE.