BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX35MM

    MDR report key: 3081214 · Received April 26, 2013

    Report

    Report Number
    1818910-2013-06658
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    April 16, 2013
    Report Date
    July 29, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NDJ
    PMA / PMN Number
    K983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE: (B)(6) 2013 - AMENDED LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM GRINDING AND POPPING, INFLAMMATION, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL ION PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. DATE OF IMPLANT HAS ALSO BEEN PROVIDED. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    UPDATE: (B)(4) 2013 - IT HAS BEEN REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED ON (B)(6) 2013 TO ADDRESS PAIN; HOWEVER, ACCORDING TO THE PART AND LOT INFORMATION PROVIDED, THE PARTS THAT WERE REMOVED WERE PINNACLE, RATHER THAN ASR. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER RELATED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. 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 THE PRODUCT OR 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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED OTHER REPORTS AGAINST THE ACETABULAR INSERT AND FEMORAL HEAD. PER PROCEDURE, THESE DEVICES ARE EXEMPT FROM DEVICE HISTORY RECORD REVIEW. ONE OTHER REPORT WAS FOUND AGAINST THE PRODUCT 121735500 LOT C56FL4000. REVIEW OF DEVICE HISTORY RECORDS IDENTIFIED NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED NO OTHER REPORTS AGAINST THE REMAINING PRODUCT/LOT CODE COMBINATIONS. 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.

    Description of Event or Problem · 1

    LITIGATION ALLEGED THE PATIENT SUFFERED PAIN AND DISCOMFORT AS A RESULT OF THE IMPLANTED ASR HIP. DOI: UNKNOWN - DOR: NONE REPORTED (RIGHT HIP). PT IS A RESIDENT OF THE STATE OF (B)(6). UPDATE - IT HAS BEEN REPORTED THAT THE PATIENTS RIGHT HIP WAS REVISED ON (B)(6) 2013 TO ADDRESS PAIN; HOWEVER, ACCORDING TO THE PART AND LOT INFORMATION PROVIDED, THE PARTS THAT WERE REMOVED WERE PINNACLE, RATHER THAN ASR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181526 PINN CAN BONE SCREW 6.5MMX35MM BONE SCREW NDJ DEPUY ORTHOPAEDICS INC US C56FL4000

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention