BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY PINNACLE HEAD

    MDR report key: 3924323 · Received July 9, 2014

    Report

    Report Number
    1818910-2014-23035
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    March 20, 2014
    Report Date
    June 18, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KXA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. 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

    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. MEDICAL RECORDS WERE RECEIVED AND REVIEWED. FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION AVAILABLE, THE COMPLAINT IS NOT PRODUCT RELATED. THE SURGEON NOTED A MORE VERTICAL PLACEMENT OF THE PREVIOUS ACETABULAR COMPONENT ASWELL AS THE PATIENT HAD SIGNIFICANT SOFT TISSUE LAXITY AND WAS MORBIDLY OBESE. MALPOSITIONED DEVICES CAN INCREASE THE CONTACT ZONE BETWEEN THE FEMORAL HEAD AND THE RIM OF THE LINER CAUSING EDGE LOADING, WHICH ADVERSELY AFFECTS LOADING OF THE BEARING AND INCREASES WEAR RATES. IFU¿S CAUTION THAT IT IS IMPERATIVE THAT THE PATIENT BE INSTRUCTED ABOUT THE STRENGTH LIMITATIONS OF THE MATERIALS USED IN THE DEVICE AND FOR IMPLANT FIXATIONS. OBESITY IMPOSES SEVERE LOADING ON THE AFFECTED EXTREMITY SIGNIFICANTLY INCREASING WEAR AND THE LIKELIHOOD OF EARLY FAILURE, INCLUDING LOOSENING, OF ONE OR MORE OF THE COMPONENTS. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN 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.

    Description of Event or Problem · 1

    LEGAL CLAIM RECEIVED. CLAIM ALLEGES PAIN, INCREASED METAL IONS, AND METAL DEBRIS. AFTER REVIEW OF THE MEDICAL RECORDS PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2005, BUT THE LINER WAS REVISED ON (B)(6) 2006. THIS REVISION IS ALREADY ON ANTHER COMPLAINT. THE PATIENT WAS REVISED AGAIN (B)(6) 2014 FOR HIGH METAL IONS AND METAL DEBRIS. AFTER REVIEW OF THE REVISION OPERATIVE NOTE THE CUP WAS REVISED FOR MALPOSITIONING. THERE WAS NO MENTION OF METALLOSIS, ONLY METAL DEBRIS.

    Description of Event or Problem · 1

    "DEPUY PINNACLE HIP REPLACEMENT FAILURE. TOTAL LEFT HIP REVISION SURGERY DUE TO FAILURE CAUSING IMPLANT DISLOCATION IN 2012 AND 2013. ELEVATED COBALT AND CHROMIUM LEVEL RESULTING IN METALLOSIS AND NECROSIS. FEMUR FRACTURE IN 2013, NUMBNESS, DIFFICULTY WALKING, LEFT LEG ONE HALF INCHES LONGER THEN RIGHT LEG AND EXTREME HIP DISLOCATION PERSUASIONS." DUE TO THE COMPLAINT MENTIONING ELEVATED METAL ION LEVELS, THE STEM IS BEING ADDED TO THE COMPLAINT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399960 UNKNOWN DEPUY PINNACLE HEAD HIP FEMORAL HEAD KXA DEPUY ORTHOPAEDICS INC US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention