BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX OPTION TAPER SLEVE 0MM

    MDR report key: 22182204 · Received June 11, 2025

    Report

    Report Number
    3002806535-2025-00229
    Event Type
    Injury
    Date Received
    June 11, 2025
    Date of Event
    January 2, 2025
    Report Date
    October 14, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271489
    PMA / PMN Number
    K192683
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 650-1058, CER BIOLOXD OPTION HD 40MM, LOT 3111577, 10010246, G7 OSSEOTI 4 HOLE SHELL, LOT 65273587, 51-149080, TPRLC XR MP FP T1 PPS, LOT 7148678, 30124006, 40MM I.D. SIZE F HIGH WALL LINER, LOT 65323993. 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, H2, H3, H6, H10, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS CONFIRMED THE REPORTED EVENT. 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 IN A CLINICAL STUDY THAT APPROXIMATELY TWO YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO SEVERE PAIN AND FAILED IMPLANTS. PATIENT EXPERIENCED PAIN, WEAKNESS, TROCHANTERIC BURSITIS, AND POSSIBLE ILIOPSOAS TENDINITIS. THE SHELL WAS RETAINED AND ALL OTHER IMPLANTS REVISED. 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
    92488 BIOLOX OPTION TAPER SLEVE 0MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO BIOMET UK LTD. 3111783 00887868271489

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H11 NARRATIVE.