BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS 3CM DIAPHYSEL SEGMENT

    MDR report key: 5027749 · Received August 25, 2015

    Report

    Report Number
    0001825034-2015-03806
    Event Type
    Injury
    Date Received
    August 25, 2015
    Date of Event
    July 28, 2015
    Report Date
    October 15, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. PRODUCT LEFT CONFORMING TO PRINT AS THERE WAS NO EVIDENCE THAT STATES OTHERWISE. THE PRODUCT UNDERWENT A DESIGN CHANGE IN MARCH 2013 TO STRENGTHEN THE COMPONENT. PRIOR TO THE CHANGE, THE FREQUENCY OF TAPER FRACTURE EVENTS WAS WITHIN ACCEPTABLE LEVELS. BASED ON THESE RESULTS THE COMPLAINT IS CONSIDERED CONFIRMED. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-03806-2 / 03807-2).

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 9 STATES, "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT." DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS. THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-03804 / 03807).

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL ORTHOPEDIC SALVAGE SYSTEM KNEE PROCEDURE ON (B)(6) 2006. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2009 DUE TO POSSIBLE INFECTION. THE HINGE COMPONENTS AND TIBIAL BEARING WERE REMOVED AND REPLACED AND A TAPER ADAPTER WAS IMPLANTED. PATIENT WAS REVISED AGAIN ON (B)(6) 2012 DUE TO A LOOSE STEM. THE HINGE COMPONENTS, TAPER ADAPTER, AND TIBIAL BEARING WERE REMOVED AND REPLACED. PATIENT UNDERWENT A SECOND REVISION ON (B)(6) 2015 DUE TO UNKNOWN REASONS TO PERFORM A POLY SWAP. DURING THE PROCEDURE IT WAS NOTED THAT THE COMPRESS ADAPTOR JUNCTION FRACTURED BETWEEN THE COMPRESS ADAPTOR AND THE DIAPHYSEAL SEGMENT. THE HINGED COMPONENTS AND TIBIAL BEARING WERE REMOVED AND REPLACED. PATIENT UNDERWENT A THIRD REVISION ON (B)(6) 2015 DUE TO THE COMPONENT FRACTURE. THE TAPER ADAPTER, DISTAL FEMUR, DIAPHYSEAL, LOCKING PIN, AND STACKING ADAPTER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561211 OSS 3CM DIAPHYSEL SEGMENT PROSTHESIS, KNEE JDI BIOMET ORTHOPEDICS N/A 753960

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R