BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOLOX OPTION TYPE 1 TPR SLEVE +6

    MDR report key: 21593579 · Received March 13, 2025

    Report

    Report Number
    3002806535-2025-00117
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    February 12, 2025
    Report Date
    July 14, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    UDI-DI
    00887868271502
    PMA / PMN Number
    K192683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D-10: 650-1058, CER BIOLOXD OPTION HD 40MM, LOT#: 3213632. 51-104160, TPRLC 133 T1 PPS HO 16X152MM, LOT#: 6994024. 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: 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. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CANNOT BE CONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE SURGERY ADAPTER MAY HAVE NOT SEATED CORRECTLY ON THE STEM, WHICH CAUSED THE HEAD TO POTENTIALLY SIT HIGHER THAN IT SHOULD HAVE. THE SURGEON TRIED TO SEPARATE THE HEAD/TAPER FROM THE STEM, BUT THE TAPER REMAINED ON THE STEM WHILE THE HEAD SEPARATED FROM THE TAPER. HE HAD TO REPLACE THAT STEM WITH A NEW STEM AS THE TAPER WOULD NOT DISENGAGE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689145 BIOLOX OPTION TYPE 1 TPR SLEVE +6 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, JDI BIOMET UK LTD. 3141057 00887868271502

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male SEE H11 NARRATIVE.