BEUDAMED
    FDA Adverse Event Injury Summary report: N

    25MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-025

    MDR report key: 22834516 · Received August 18, 2025

    Report

    Report Number
    0002249697-2025-00887
    Event Type
    Injury
    Date Received
    August 18, 2025
    Date of Event
    July 24, 2025
    Report Date
    December 19, 2025
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    04546540641090
    PMA / PMN Number
    K121308
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT AN EVENT REGARDING CRACK/FRACTURE INVOLVING A RESTORATION MODULAR BODY WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS -PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION: THE REPORTED DEVICE WAS NOT RETURNED HOWEVER PHOTOGRAPHS WERE PROVIDED FOR REVIEW. THE PHOTOGRAPHS SHOW A RECENTLY EXPLANTED RESTORATION MODULAR BODY AND METAL HEAD. THE HEAD REMAINS ATTACHED TO THE FRACTURED NECK. FROM THE PHOTOGRAPHS PROVIDED THE EVENT CAN BE CONFIRMED. MATERIAL ANALYSIS, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. -CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: 'THE FIRST X-RAY SHOWS AN INTACT RESTORATION MODULAR STEM WITH TROCHANTERIC WIRES. THE SECOND X-RAY SHOWS A RESTORATION MODULAR STEM WITH A FRACTURE THROUGH THE TRUNNION THAT IS DISPLACED AND ANGULATED. A RESTORATION MODULAR STEM WITH A COMPLETE FRACTURE THROUGH THE TRUNNION IS CONFIRMED. THE ROOT CAUSE FOR THIS MECHANICAL COMPLICATION CANNOT BE DETERMINED FROM THE DOCUMENTATION PROVIDED. SHOULD FURTHER DOCUMENTATION BECOME AVAILABLE, I WOULD BE HAPPY TO FURTHER THIS INVESTIGATION.' -PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE THE REPORTED DEVICE WAS MANUFACTURED WITH NO REPORTED RELEVANT DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO THE TRUNNION OF THE RESTORATION MODULAR CONE BODY FRACTURING APPROXIMATELY 1/4 INCH TO 1/2 INCH BACK FROM THE FEMORAL HEAD. THE HEAD AND PROXIMAL BODY WERE REVISED. A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: 'THE FIRST X-RAY SHOWS AN INTACT RESTORATION MODULAR STEM WITH TROCHANTERIC WIRES. THE SECOND X-RAY SHOWS A RESTORATION MODULAR STEM WITH A FRACTURE THROUGH THE TRUNNION THAT IS DISPLACED AND ANGULATED. A RESTORATION MODULAR STEM WITH A COMPLETE FRACTURE THROUGH THE TRUNNION IS CONFIRMED. THE ROOT CAUSE FOR THIS MECHANICAL COMPLICATION CANNOT BE DETERMINED FROM THE DOCUMENTATION PROVIDED. THE REPORTED DEVICE WAS NOT RETURNED HOWEVER PHOTOGRAPHS WERE PROVIDED FOR REVIEW. THE PHOTOGRAPHS SHOW A RECENTLY EXPLANTED RESTORATION MODULAR BODY AND METAL HEAD. THE HEAD REMAINS ATTACHED TO THE FRACTURED NECK. FROM THE PHOTOGRAPHS PROVIDED THE EVENT CAN BE CONFIRMED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO THE TRUNNION OF THE RESTORATION MODULAR CONE BODY FRACTURING APPROXIMATELY 1/4 INCH TO 1/2 INCH BACK FROM THE FEMORAL HEAD. THE HEAD AND PROXIMAL BODY WERE REVISED. REP WILL PROVIDE ALL AVAILABLE INFORMATION WHEN PI CONFIRMATION IS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2194116 25MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-025 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 89266101 04546540641090

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention| H