BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX NEUT 36IDX56OD

    MDR report key: 2112817 · Received May 18, 2011

    Report

    Report Number
    1818910-2011-08789
    Event Type
    Injury
    Date Received
    May 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    K062148
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED AND ARE PRESUMED YET IMPLANTED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY 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

    THE 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.

    Additional Manufacturer Narrative · 1

    UPDATE: 10/17/2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. ALTHOUGH LITIGATION REPORTED THIS AS METAL ON METAL, PRODUCT INFORMATION INDICATES THE PATIENT HAD POLY ON METAL. AS THE LITIGATION HAS ALREADY BEEN REPORTED, AND THERE IS NO REPORTED SERIOUS INJURY OR MALFUNCTION (PATIENT HAS NOT BEEN REVISED), THE REPORTING REQUIREMENTS HAVE BEEN MET. EVEN THOUGH PART/LOT INFORMATION WAS PROVIDED IT IS UNCLEAR WHAT PRODUCTS ARE AT ISSUE AS THE PATIENT HAS NOT BEEN REVISED THEREFORE THE PRODUCT PAGE WILL BE LEFT AS UNKNOWN UNTIL FURTHER INFORMATION IS RECEIVED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. DOI: (B)(6) 2009 (LEFT SIDE) - DOR: N/I. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6) 2009, PATIENT WAS IMPLANTED WITH A PINNACLE TOTAL HIP REPLACEMENT ON HIS LEFT SIDE. ON OR ABOUT (B)(6) 2010, WHILE BENDING DOWN UNDER NORMAL CIRCUMSTANCES, PATIENT FELT A "POPPING" SENSATION IN HIS LEFT HIP, CAUSING HIM TO FALL BACKWARDS INJURING HIS WRISTS. SINCE (B)(6) 2010, IT IS ALLEGED THAT THE PATIENT HAS HAD PROBLEMS WITH HIS LEFT HIP, INCLUDING DIFFICULTY WITH BENDING AND WALKING, AND PARTIAL OR COMPLETE LACK OF MOBILITY. ADDITIONALLY, IT IS ALLEGED THAT THE PATIENT MAY NEED REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRX NEUT 36IDX56OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS LPH DEPUY ORTHOPAEDICS INC US NA DD1CB1000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention