BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX54OD

    MDR report key: 2701754 · Received August 16, 2012

    Report

    Report Number
    1818910-2012-19075
    Event Type
    Injury
    Date Received
    August 16, 2012
    Date of Event
    August 15, 2012
    Report Date
    February 6, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    K003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    **UPDATE** 10/25/2012- LITIGATION PAPERS RECEIVED. IN ADDITION TO PREVIOUSLY REPORTED ALLEGATIONS, IT IS NOW ALLEGED THAT THE PATIENT SUFFERS FROM METALLOSIS AND LOOSENING. AN UNKNOWN DEVICE HAS BEEN ADDED TO ENSURE COVERAGE FOR ALLEGED LOOSENING.

    Additional Manufacturer Narrative · 1

    **UPDATE** 10/25/2012- LITIGATION PAPERS RECEIVED. IN ADDITION TO PREVIOUSLY REPORTED ALLEGATIONS, IT IS NOW ALLEGED THAT THE PATIENT SUFFERS FROM METALLOSIS AND LOOSENING. AN UNKNOWN DEVICE HAS BEEN ADDED TO ENSURE COVERAGE FOR ALLEGED LOOSENING. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE CORRECTIVE ACTION WAS NOT ESTABLISHED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. C. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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

    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

    PATIENT WAS REVISED TO ADDRESS AN ADVERSE TISSUE REACTION, WITH PAIN AND SWELLING NEAR HIP.

    Description of Event or Problem · 1

    UPDATE (B)(6) 2017 - (TRANSFER WPC 12316-2012) PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISING SURGEON IN HIS SURGICAL INDICATIONS REPORTED THAT A PRE-OP ASPIRATION OF PATIENT'S RIGHT HIP ONE WEEK PRIOR "RETURNED MOTOR OIL-LIKE FLUID FROM THE RIGHT HIP". OPERATIVE NOTE INDICATED "EVIDENCE OF BROWNISH CAPSULAR TISSUE INDICATIVE OF EARLY ADVERSE LOCAL TISSUE REACTION". ALSO, "THERE WAS A SMALL AMOUNT OF EVIDENCE OF CORROSION FROM THE HEAD-TRUNNION INTERFACE". THERE WERE NO IDENTIFIED LOOSE COMPONENTS. POST-OP DIAGNOSIS "ADVERSE LOCAL TISSUE REACTION, RIGHT HIP". PATHOLOGY REPORT OF REVISION HIP CAPSULE TISSUE STATES "PATCHY DENSE PERIVASCULAR LYMPHOCYTE INFLAMMATION IS PRESENT CONSISTENT WITH THE HISTORY OF METAL-ON-METAL REACTION". METAL ION LABS REPORTED < 7.0 PPB. THE UNKNOWN DEVICE WILL BE ASSIGNED AS STEM AND CODED FOR CORROSION HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT36IDX54OD ACETABULAR LINER KWA DEPUY ORTHOPAEDICS INC US 2491570

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention