BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER SLEEVES 12/14 +2

    MDR report key: 2792662 · Received October 16, 2012

    Report

    Report Number
    1818910-2012-76365
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    March 17, 2010
    Report Date
    September 21, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES AND/OR A REVIEW OF DEVICE HISTORY RECORDS WERE NOT POSSIBLE AS THE REQUIRED PRODUCT/LOT CODE COMBINATIONS WERE NOT PROVIDED. THE INVESTIGATION CAN DRAW NO CONCLUSION REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR FURTHER CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD PAIN, METAL-INDUCED SYNOVITIS/IMMUNE RESPONSE, ASEPTIC METAL INFLAMMATORY REACTION, TISSUE DEATH, HIGH CHROMIUM LEVELS AND LEG LENGTH INEQUITY AFTER ASR HIP IMPLANT.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO PAIN, ALVAL AND SQUEAKING. INFORMATION WAS RECEIVED FROM THE RETRIEVAL LAB. UPDATE: 10/16/2012 - LITIGATION RECEIVED (B)(4) 2012 AND ATTACHED. COMPLAINT CHANGED TO LEGAL. DOB ADDED. DOI: (B)(6) 2006. (LEFT HIP) LITIGATION ALLEGES PATIENT HAD PAIN, METAL-INDUCED SYNOVITIS/IMMUNE RESPONSE, ASEPTIC METAL INFLAMMATORY REACTION, TISSUE DEATH, HIGH CHROMIUM LEVELS AND LEG LENGTH INEQUITY AFTER ASR HIP IMPLANT. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION EXCEPT PRODUCTS ADDED (IMPLANTS TO CUP, ADDED HEAD, STEM AND SLEEVE) AND REPORTED. UPDATE: (B)(6) 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED (PART/LOT) INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE: (B)(6) 20/12 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION FOR THE SLEEVE ADAPTER. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTER SLEEVES 12/14 +2 SLEEVE - HIP IMPLANT KWA DEPUY INTERNATIONAL 2129467

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention