BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM NRH TIB SLEEVE POR 53MM

    MDR report key: 4191940 · Received October 22, 2014

    Report

    Report Number
    1818910-2014-30382
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    May 30, 2014
    Report Date
    September 23, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JWH
    PMA / PMN Number
    PK870730
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED SROM NRHFEM W/PIN MED RT 71X66 CONFIRMED THE REPORTED FRACTURE. THE STEM OF THE FEMORAL COMPONENT WAS FRACTURED AS A RESULT OF LOW STRESS HIGH CYCLE FATIGUE CRACK INITIATION AND PROPAGATION. NO MATERIAL DEFECTS WERE OBSERVED THAT COULD HAVE CONTRIBUTED TO FRACTURE INITIATION AND/OR PROPAGATION TO FAILURE. THERE WAS NO EVIDENCE OF BONE INGROWTH INTO THE POROUS COATING OF THE IMPLANT AND IT FRACTURED AS A RESULT OF LOW STRESS HIGH CYCLE FATIGUE CRACK INITIATION AND PROPAGATION. IT IS NOT KNOWN TO WHAT EXTENT THE PATIENT¿S HISTORY OF PERIPHERAL VASCULAR DISEASE, OBESITY AND SMOKING CONTRIBUTED TO THE COMPLAINT ¿ THESE COULD INHIBIT BONE GROWTH AND THE LACK OF FIXATION COULD RESULT IN THE IMPLANT FATIQUE AND FRACTURE. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    IMPLANTATION OF S-ROM NOILES KNEE IN 2007. INSTABILITY SINCE (B)(6) 2014. REVISION (B)(6) 2014. DURING REVISION PIN BREAKAGE AT FEMUR BECAME OBVIOUS. EXPLANTATION OF COMPLETE CONSTRUCT. REVIEW OF MEDICAL RECORDS CONFIRM REASON FOR REVISION AS - FRACTURING OF THE CENTRAL AXIS OF THE S-ROM FEMORAL PROSTHESIS IN THE PATIENT¿S RIGHT KNEE WITH LOOSENING OF THE FEMORAL CONDYLE AND THE TIBIAL PROSTHESIS - KM 23/9/14

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671710 SROM NRH TIB SLEEVE POR 53MM KNEE OTHER IMPLANT JWH DEPUY ORTHOPAEDICS, INC. 1818910 137453PB

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention