BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSS MODULAR PROXIMAL TIBIA

    MDR report key: 6191317 · Received December 20, 2016

    Report

    Report Number
    0001825034-2016-05279
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    November 25, 2016
    Report Date
    August 24, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KRO
    PMA / PMN Number
    PK052685
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT EXPLANTED. CONCOMITANT MEDICAL PRODUCTS: OSS INTERLOK STRAIGHT IM STEM WITH SCREW, CATALOG#: 150446, LOT#: 023950. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2016-05279, 0001825034-2017-06752. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. 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

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-05279 / 05290).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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

    DURING AN ORTHOPEDIC SALVAGE SYSTEM REVISION PROCEDURE, UPON REMOVAL OF THE MATING SCREW, THE PROXIMAL TIBIAL COMPONENT AND STEM WERE UNABLE TO BE DISENGAGED.

    Description of Event or Problem · 1

    DURING AN ORTHOPEDIC SALVAGE SYSTEM REVISION PROCEDURE UPON REMOVAL OF THE MATING SCREW, THE PROXIMAL TIBIAL COMPONENT AND STEM WERE UNABLE TO DISENGAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839290 OSS MODULAR PROXIMAL TIBIA PROSTHESIS, KNEE KRO BIOMET ORTHOPEDICS N/A 811890

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR