BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM*STM ST,36+8L NK,18X13X160

    MDR report key: 3491194 · Received November 27, 2013

    Report

    Report Number
    1818910-2013-34601
    Event Type
    Injury
    Date Received
    November 27, 2013
    Date of Event
    May 21, 2011
    Report Date
    November 1, 2013
    Manufacturer
    DEPUY IRELAND REG. # 9616671
    Product Code
    KXA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. 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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. REVIEW OF THE PROVIDED MEDICAL RECORDS BY DEPUY CPD FINDS THE COMPLAINANT REPORTED PAIN, LOOSENING OF THE SLEEVE/STEM, ALVAL AND METALLOSIS. THIS WAS PARTIALLY CONFIRMED. PAIN, LOOSENING AND POSSIBLE ALVAL WAS REPORTED. METALLOSIS WAS NOT REPORTED IN THE HISTOLOGY. FROM A CPD ENGINEERING PERSPECTIVE IT IS NOT POSSIBLE TO DETERMINE WHAT SPECIFIC IMPLANT RELATED FACTORS IF ANY, LEAD TO THE NEED FOR REVISION. A SEARCH OF THE COMPLAINTS DATABASES FOUND OTHER REPORTS AGAINST THE PROVIDED FEMORAL HEAD AND ACETABULAR LINER PRODUCT/LOT CODE COMBINATIONS. REVIEW OF DEVICE HISTORY RECORDS FOR THE 1081114 LOT CODE FOUND NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE REMAINDER OF THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. REVIEW OF THE PROVIDED MEDICAL RECORDS BY DEPUY CPD FINDS THE COMPLAINANT REPORTED PAIN, LOOSENING OF THE SLEEVE/STEM, ALVAL AND METALLOSIS. THIS WAS PARTIALLY CONFIRMED. PAIN, LOOSENING AND POSSIBLE ALVAL WAS REPORTED. METALLOSIS WAS NOT REPORTED IN THE HISTOLOGY. FROM A CPD ENGINEERING PERSPECTIVE IT IS NOT POSSIBLE TO DETERMINE WHAT SPECIFIC IMPLANT RELATED FACTORS IF ANY, LEAD TO THE NEED FOR REVISION. X-RAYS WERE RECEIVED AND REVIEWED. 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. CORRECT COMPONENT PLACEMENT IS CRITICAL FOR THE LONGEVITY OF THE HIP RECONSTRUCTION AND EVEN MORE CRITICAL WHEN ALTERNATIVE BEARINGS ARE USED IN THE RECONSTRUCTION. A SEARCH OF THE COMPLAINTS DATABASES FOUND OTHER REPORTS AGAINST THE PRODUCT/LOT CODE COMBINATIONS. REVIEW OF DEVICE HISTORY RECORDS FOUND NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Description of Event or Problem · 1

    PINNACLE MOM REVISION DUE TO PAIN, LOOSENING OF THE SLEEVE/STEM, ALVAL AND METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618108 SROM*STM ST,36+8L NK,18X13X160 FEMORAL STEM KXA DEPUY IRELAND REG. # 9616671 1825394

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention