BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURON 10D 56 OR 68ODX28ID

    MDR report key: 3894957 · Received June 25, 2014

    Report

    Report Number
    1818910-2014-21967
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    DEPUY INTL., LTD. ¿ REG. # 8010379
    Product Code
    JDI
    PMA / PMN Number
    PK900832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    Additional Manufacturer Narrative · 1

    THE COMPLAINT STATES THAT THE PATIENT WAS REVISED DUE TO THE STEM¿S NECK FRACTURE ON (B)(6) 2014. DOI - (B)(6) 2003. THE STEM, THE HEAD AND THE LINER WERE REPLACED DURING THE REVISE SURGERY. REVIEW OF MANUFACTURING RECORDS AND COMPLAINT DATABASE SEARCH DID NOT IDENTIFY ANY ANOMALIES. REVIEW OF MANUFACTURING RECORDS AND COMPLAINT DATABASE SEARCH DID NOT IDENTIFY ANY ANOMALIES. THE PRODUCTS AND LAB REPORT WERE TRANSFERRED TO BIOENGINEERING FOR REVIEW. A REPORT WAS RECEIVED STATING THE PATIENT WAS A (B)(6) MALE OF UNKNOWN WEIGHT AND HEIGHT. THE IMPLANT WAS IN SITU FOR 3893 DAYS (APPROX. 10 ½ YEARS). THE PRODUCTS WERE RETURNED FOR REVIEW AND HAVE BEEN REVIEWED IN DETAIL BY A THIRD PARTY AND INTERNALLY (L00001213). BOTH REPORTS DESCRIBE THE FAILURE MECHANISM, WITH L00001213 INCLUDING THE FOLLOWING STATEMENT WITHIN THE SUMMARY: ¿CRACKS OBSERVED ON THE VISIBLE PART OF THE MALE TAPER SURFACE AND THROUGH THE CROSS-SECTION OF THE NECK SUGGEST THAT TENSILE STRESSES ACTING ON THIS REGION MAY HAVE CAUSED CRACKS PROPAGATION THROUGH THE NECK ALONG THE GRAIN BOUNDARIES. THE FINDINGS OF THIS INVESTIGATION ARE CONSISTENT WITH THOSE MADE DURING THE INVESTIGATION BY THE THIRD PARTY.¿ WHILST THE ANALYSIS ON THE RETURNED PRODUCT GAVE INFORMATION ON THE FRACTURE MECHANISM, IT DID NOT DETERMINE A ROOT CAUSE FOR THIS FAILURE. NO INFORMATION IS AVAILABLE REGARDING OTHER POTENTIAL INFLUENCES SUCH AS SURGICAL PROCESS, IMPLANT POSITIONING AND PATIENT VARIABLES E.G. ACTIVITY, WEIGHT, BMI, ANATOMICAL CONSIDERATIONS AND PATIENT CHANGES OVER TIME THEREFORE THE ROOT CAUSE IS UNDETERMINED. THE MODE OF FAILURE OF THE PROSTHESIS IS MULTI-FACTORIAL AND CONSIDERATION HAS TO BE GIVEN TO ALL OTHER POTENTIAL INFLUENCES SUCH AS, SURGICAL PROCESS, PATIENT VARIABLES I.E. ACTIVITY, WEIGHT, BMI AND USE, ANATOMICAL CONSIDERATIONS AND PATIENT CHANGES OVER TIME. THIS REPORT DETAILS THE FINDING OF REVIEW OF THE EXPLANTS AND INFORMATION AS SUPPLIED AT THE TIME OF EVALUATION. ANY CONCLUSIONS FROM THIS DATA HAVE TO BE PLACED INTO CONTEXT WITH ALL OTHER RELEVANT FACTORS. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS. IF FURTHER INFORMATION IS RECEIVED THE COMPLAINT SHALL BE REOPENED AND INVESTIGATED FURTHER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED DUE TO THE STEM¿S NECK FRACTURE ON (B)(6) 2014. DOI (B)(6) 2003. THE STEM, THE HEAD AND THE LINER WERE REPLACED DURING THE REVISE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370886 ENDURON 10D 56 OR 68ODX28ID HIP ACETABULAR INSERT/LINER JDI DEPUY INTL., LTD. ¿ REG. # 8010379 1086320

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other