BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIDENTIFIED 12.5MM POLY

    MDR report key: 3073104 · Received April 23, 2013

    Report

    Report Number
    1818910-2013-15777
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE COMPLAINT WAS RECEIVED INTO THE LEEDS QUALITY DEPARTMENT (B)(6) 2013 WITH NOTIFICATION THAT THE PRODUCTS WERE DISCARDED AND THAT LOT NUMBER INFORMATION WAS NOT AVAILABLE. REQUESTS FOR PRODUCT CODE INFORMATION WERE MADE (B)(6) 2013. TO DATE, NO FURTHER INFORMATION HAS BEEN RECEIVED. FOLLOWING RECEIPT OF PATIENT X-RAY AND PHOTOGRAPH ATTACHMENTS, THE INVESTIGATION WAS TRANSFERRED TO BIOENGINEERING (B)(6) 2013. A REPORT WAS RECEIVED FROM BIOENGINEERING (B)(6) 2013, ADVISING: CONCLUSION: DOB (B)(6), DOR (B)(6) 2013, DOI 1996. MALE. NO POST PRIMARY OR INTERVENING X-RAYS ARE PROVIDED FOR REVIEW. THE IMPLANT FAILED AFTER MORE THAN 15 YEARS. THE DEVICE WAS IMPLANTED IN 1996 AND THEREFORE IT MAY BE GAMMA-IN-AIR OR GVF OR ANOTHER STERILIZATION METHOD. NO LOT ID WAS PROVIDED. THE IMAGE IS BLURRY AND IT IS NOT POSSIBLE TO SAY IF IT IS GROSSLY OXIDIZED. ROOT CAUSE: UNDETERMINABLE, AFTER MORE THAN 15 YEARS IT WOULD SEEM UNLIKELY THERE IS A MANUFACTURING FAULT BUT IT IS NOT POSSIBLE TO CONFIRM THIS DUE TO THE LIMITED INFORMATION. IT IS LIKELY IN THIS CASES THAT AN UNKNOWN COMBINATION OF FACTORS ¿ SUCH AS PATIENT FACTORS, SURGICAL PROCEDURE, SURGICAL PROCESS AND IMPLANT DESIGN ¿ MAY HAVE LEAD TO THE REVISION. POST MARKET SURVEILLANCE IS (B)(4). DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    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

    CONCLUSION AND JUSTIFICATION STATUS: FOLLOWING INVESTIGATION BY BIOENGINEERING, NOTIFICATION WAS RECEIVED THAT: ROOT CAUSE: UNDETERMINABLE, AFTER MORE THAN 15 YEARS IT WOULD SEEM UNLIKELY THERE IS A MANUFACTURING FAULT BUT IT IS NOT POSSIBLE TO CONFIRM THIS DUE TO THE LIMITED INFORMATION. IT IS LIKELY IN THIS CASES THAT AN UNKNOWN COMBINATION OF FACTORS ¿ SUCH AS PATIENT FACTORS, SURGICAL PROCEDURE, SURGICAL PROCESS AND IMPLANT DESIGN ¿ MAY HAVE LEAD TO THE REVISION. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS.

    Description of Event or Problem · 1

    REASON FOR REVISION: THE POLY FRACTURED. ALL OTHER COMPONENTS ARE FIXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174665 UNIDENTIFIED 12.5MM POLY TIBIAL INSERT JWH DEPUY ORTHOPAEDICS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention