BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONO REV STEM STD 22X245

    MDR report key: 19177729 · Received April 24, 2024

    Report

    Report Number
    1038671-2024-00968
    Event Type
    Injury
    Date Received
    April 24, 2024
    Date of Event
    April 3, 2024
    Report Date
    August 19, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    LZO
    UDI-DI
    10885862282163
    PMA / PMN Number
    K150066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PENDING INVESTIGATION. D10: 7232356 170-40-00 - BIOLOX DELTA FEMORAL 40MM OD, +0MM.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H4, H6 MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, G THE REASON FOR THE REVISION REPORTED WAS LIKELY DUE TO A PERIPROSTHETIC BONE FRACTURE. THE CAUSE OF THE BONE FRACTURE CANNOT BE CONCLUSIVELY DETERMINED BUT MAY BE RELATED TO A PATIENT CONDITION AND/OR SURGICAL TECHNIQUES. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN ORIGINAL COMPETITORS TOTAL HIP REPLACEMENT. THE PATIENT HAD REVISION SURGERY ON (B)(6) 2024 FOR METAL-ON-METAL IMPLANT REVISION TO POLY AND POSSIBLE LOOSE IMPLANTS. IN THE FIRST REVISION SURGERY ON (B)(6) 2024 THE ORIGINAL COMPETITORS FEMORAL STEM PRESENTED TO BE LOOSE AND UNSTABLE. THE IMPLANT WAS REMOVED AND REPLACED WITH AN EXACTECH 22MMX245MM MONOBLOC HIP STEM AND 40MM +0MM HEAD AND A COMPETITORS POLY LINER IN THE ORIGINAL CUP. IT WAS NOTED IN THE REVISION SURGERY THAT THE PATIENT HAD THIN PROXIMAL FEMORAL CORTICES. POSTOPERATIVELY THE PATIENT PRESENTED BACK TO THE SURGEON'S OFFICE WITH A HAIRLINE FEMUR FRACTURE TO WHICH THE PATIENT WAS MADE NON-WEIGHT BEARING. THE PATIENT PRESENTED BACK WITH A DISPLACED FEMORAL HIP FRACTURE THAT REQUIRED REVISION SURGERY TO ORIF. THE SECOND REVISION HIP SURGERY FOR FEMORAL FRACTURE WAS SCHEDULED FOR (B)(6) 2024. THE PATIENT WAS REVISED TO A 22MMX295MM MONOBLOC HIP STEM AND 40MM +0MM HEAD ALONG WITH A LATER FEMORAL HIP DIFFERENT COMPETITORS FRACTURE PLATE, SCREW, AND CABLES. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160690 MONO REV STEM STD 22X245 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO EXACTECH, INC. 10885862282163

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention SEE H10.