BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX NEUT 32IDX54OD

    MDR report key: 3132838 · Received May 29, 2013

    Report

    Report Number
    1818910-2013-17733
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    March 8, 2010
    Report Date
    August 2, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC./REG. #1818910
    Product Code
    LPH
    PMA / PMN Number
    PK072963
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE PATIENT WAS REVISED BECAUSE OF DISLOCATION. DOI: (B)(6) 2009 DOR: (B)(6) 2010 (UNKNOWN HIP). UPDATE 08/02/2013 - PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE THAT THE PATIENT HAD A DISLOCATED LEFT HIP AND ON (B)(6) 2009 UNDERWENT AN OPEN REDUCTION, WITHOUT COMPONENT EXCHANGE. THE PATIENT THEN DISLOCATED AGAIN ON (B)(6) 2010 WHERE THE PATIENT HAD ANOTHER OPEN REDUCTION AND COMPONENT EXCHANGE. UPON REVISION THERE WAS A LARGE AMOUNT OF HEMATOMA FOUND IN THE HIP. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. (LEFT HIP). UPDATE 08/23/2013 - PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION THERE WAS 1 SCREW THAT WAS FOUND TO HAVE PROMINENCE OF THE HEAD AND WAS THEREFORE REMOVED. ALSO NOTED WAS A HEMATOMA WHICH WAS EVACUATED OUT. THE SCREW IS BEING ADDED TO THE COMPLAINT. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PROVIDED PRODUCT/LOT COMBINATIONS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE FOR THE SCREW AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE CONDUCTED. MEDICAL RECORDS, INCLUDING X-RAYS WERE OBTAINED. IT WAS NOTED THAT THE PATIENT HAD NOT FOLLOWED PRECAUTIONS AND IN ONE INSTANCE SUSTAINED A FALL. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY 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

    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

    THE PATIENT WAS REVISED BECAUSE OF DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237570 ALTRX NEUT 32IDX54OD HIP LINER LPH DEPUY ORTHOPAEDICS, INC./REG. #1818910 DH1DH1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention