BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS TIBIAL BEARING

    MDR report key: 6678733 · Received June 29, 2017

    Report

    Report Number
    0001825034-2017-04410
    Event Type
    Injury
    Date Received
    June 29, 2017
    Date of Event
    March 6, 2018
    Report Date
    May 9, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KRO
    PMA / PMN Number
    PK021260
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL PRODUCT: OSS AXLE AND BUSHING, CATALOG #: CP116410, LOT #: 753570; OSS YOKE SET, CATALOG #: CP116409, LOT #: 753320; OSS DISTAL FEMORAL COMPONENT, CATALOG #: CP116407, LOT #: 752420; OSS MODULAR TIBIAL COMPONENT, CATALOG #: CP116408, LOT #: 752690; OSS POROUS STEM, CATALOG #: 150395, LOT #: 862660; OSS POROUS STEM, CATALOG #: 150385, LOT #: 150385. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-04410; 0001825034-2018-02576; 0001825034-2018-02577.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE HAS NOT BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS IT CANNOT BE CONFIRMED WHICH STEM CAUSED THE REPORTED EVENT. THE EVENT WILL BE REPORTED ON 0001825034-2018-02576.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO LEG LENGTH DISCREPANCY. THE POLYETHYLENE BEARING AND ASSEMBLY WAS REMOVED AND REPLACED.

    Description of Event or Problem · 1

    A PATIENT WHO UNDERWENT A TOTAL KNEE ARTHROPLASTY HAS BEEN INDICATED FOR A REVISION DUE TO STEM LOOSENING. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456831 OSS TIBIAL BEARING PROSTHESIS, KNEE KRO BIOMET ORTHOPEDICS 395390

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability