BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS - CEMENTED IM STEM

    MDR report key: 6436851 · Received March 27, 2017

    Report

    Report Number
    0001825034-2017-02147
    Event Type
    Injury
    Date Received
    March 27, 2017
    Date of Event
    March 23, 2017
    Report Date
    April 28, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK123501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: OSS 3CM LEFT FEMUR, CATALOG 150351, LOT 241140; OSS TIBIAL BEARING 18MM, CATALOG 150413, LOT 991910; OSS TIBIAL SLEEVE AUGMENT, CATALOG 150455, LOT 598190; OSS LOCK PIN, CATALOG 150478, LOT 610340; OSS TIBIAL BUSHING, CATALOG 150476, LOT 594960; OSS 2PK FEMORAL BUSHINGS, CATALOG 150477, LOT 542750; OSS AXLE, CATALOG 150480, LOT 014340; OSS REINFORCED YOKE, CATALOG 150493, LOT 291400; OSS 3CM NON-MODULAR PROXIMAL TIBIA 11MM X 240MM, CATALOG 150805, LOT 623670. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT:1825034-2017-02148.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY TWO YEARS POST IMPLANTATION DUE TO FEMORAL LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218320 OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS - CEMENTED IM STEM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS 085170

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R