BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY BROACH

    MDR report key: 3201039 · Received July 2, 2013

    Report

    Report Number
    1818910-2013-20336
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    October 9, 2013
    Report Date
    October 9, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HTQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS 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 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

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES 1877771, ZT3C51000, AND ZV2BG1. A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODE 1900873 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE PART AND LOT CODE COMBINATION WAS NOT PROVIDED FOR THE UNKNOWN DEPUY BROACH. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. 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 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

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT.- LITIGATION PAPERS ALLEGE THAT THE PATIENT HAS SUFFERED PAIN, SWELLING, LACK OF MOBILITY, DAMAGE TO SURROUNDING TISSUE AND BONE CAUSED BY INFLAMMATION, METALLOSIS, PSEUDOTUMOURS, BURSITIS, AND BONE EROSION. DOI: (B)(6) 2005 - DOR: NONE REPORTED ( UNKNOWN SIDE). PATIENT IS A RESIDENT OF (B)(6). UPDATE: (B)(6) 2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. DOI: (B)(6) 2005 (LEFT HIP). RECORDS INDICATE THAT THE FEMUR WAS CRACKED DURING SURGERY. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE: (B)(6) 2013- UPON MEDICAL RECORD REVIEW BY A MEDICAL PROFESSIONAL, IT WAS DISCOVERED THAT THE FRACTURE WAS CAUSED BY BROACHING. THEREFORE, THE STEM HAS BEEN CHANGED TO AN UNKNOWN BROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303302 UNKNOWN DEPUY BROACH BROACH HTQ DEPUY ORTHOPAEDICS INC US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other