BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS POROUS IM STEM 14.5 X 150

    MDR report key: 3961485 · Received July 28, 2014

    Report

    Report Number
    0001825034-2014-06468
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    January 17, 2013
    Report Date
    September 16, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK123501
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 EVENT (REFERENCE 1825034-2014-06468 & 06469).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC SALVAGE PROCEDURE ON (B)(6) 2012. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2013 DUE TO AN UNKNOWN REASON. DURING THE PROCEDURE, THE STEM WAS REMOVED AND REPLACED. IT WAS FURTHER REPORTED THAT PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO PATIENT REQUEST TO BE CONVERTED FROM A FUSED KNEE. DURING THE PROCEDURE, THE SCREW SET WAS MISSING. ADDITIONALLY, THE TAPER ADAPTER WOULD NOT SEPARATE FROM THE OSS STEM RESULTING IN A DELAY GREATER THAN 30 MINUTES. THE PROCEDURE WAS COMPLETED BY UTILIZING A HIGH SPEED BURR TO SEPARATE THE COMPONENTS. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATES AND WHICH COMPONENTS WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC SALVAGE PROCEDURE ON (B)(6) 2012. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2013 DUE TO AN UNKNOWN REASON. DURING THE PROCEDURE, THE STEM WAS REMOVED AND REPLACED. IT WAS FURTHER REPORTED THAT PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO PATIENT REQUEST TO BE CONVERTED FROM A FUSED KNEE. DURING THE PROCEDURE, THE SCREW SET WAS MISSING. ADDITIONALLY, THE TAPERS OF THE NAIL COMPONENTS WOULD NOT SEPARATE FROM THE OSS STEM RESULTING IN A DELAY GREATER THAN 30 MINUTES. THE PROCEDURE WAS COMPLETED BY UTILIZING A HIGH SPEED BURR TO SEPARATE THE COMPONENTS. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATES AND WHICH COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438014 OSS POROUS IM STEM 14.5 X 150 PROSTHESIS, KNEE JDI BIOMET ORTHOPEDICS N/A 815760

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R