BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA CER OPTION HD 28MM

    MDR report key: 18967135 · Received March 25, 2024

    Report

    Report Number
    3002806535-2024-00108
    Event Type
    Injury
    Date Received
    March 25, 2024
    Date of Event
    February 26, 2024
    Report Date
    April 10, 2024
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271373
    PMA / PMN Number
    K200959
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, H11. 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. 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: UNKNOWN BIOMET 52X38 CUP, CAT #: UNKNOWN / LOT #: UNKNOWN. CAT # 10031009: / 28MM I.D. 38MM O.D. SIZE C BEARING / LOT #: 65931510. CAT # 650-1065 / CER OPTION TYPE 1 TPR SLEVE -3/LOT #: 3101857. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535 - 2024 - 00107. 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 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 A PATIENT UNDERWENT A REVISION, ONE MONTH POST IMPLANTATION, DUE TO UNKNOWN REASONS. A SHELL, BEARING, HEAD AND TAPER WERE REMOVED AND REPLACED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582 BIOLOX DELTA CER OPTION HD 28MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO BIOMET UK LTD. N/A 3114759 00887868271373

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H