BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY BROACH

    MDR report key: 1984365 · Received January 27, 2011

    Report

    Report Number
    1818910-2011-01137
    Event Type
    Injury
    Date Received
    January 27, 2011
    Report Date
    December 28, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: LITIGATION PAPERS ALLEGE THE BILATERAL PATIENT BEGAN TO SUFFER FROM SEVERE AND RECURRING PAIN IN BOTH HIPS, AS WELL AS, CLICKING AND POPPING. IT IS FURTHER ALLEGED THAT SHE TESTED POSITIVE FOR TOXIC LEVELS OF COBALT AND CHROMIUM. ADDITIONAL EVALUATION IS BEING PERFORMED TO DETERMINE WHEN, AND IF, REVISION SURGERY CAN BE PERFORMED. DOI: 4-5 YEARS AGO (RIGHT SIDE). DOI: (B)(6) 2008 (LEFT SIDE). THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION 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

    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

    UPDATE 10/22/2015- PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY FOR THE LEFT HIP ((B)(4)), THE PRIMARY OPERATIVE NOTE INDICATED THE SUFFERED A CRACK IN THE FEMORAL NECK WHILE REAMING JUST AS THE PATIENT DID WITH THE RIGHT SIDE. AFTER REVIEWING THE RECORDS FOR THE RIGHT HIP, THERE IS NO INDICATION OF THE FRACTURE DURING THE PRIMARY, BUT CABLES WERE REMOVED DURING THE REVISION OPERATIVE NOTE. THE UNKNOWN ASR HIP IS BEING CHANGED TO AN UNKNOWN BROACH. THE COMPLAINT WAS UPDATED ON:11/16/2015.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE BILATERAL PT BEGAN TO SUFFER FROM SEVERE AND RECURRING PAIN IN BOTH HIPS, AS WELL AS, "CLICKING AND POPPING." IT IS FURTHER ALLEGED THAT SHE TESTED POSITIVE FOR TOXIC LEVELS OF COBALT AND CHROMIUM. ADDITIONAL EVALUATION IS BEING PERFORMED TO DETERMINE WHEN, AND IF, REVISION SURGERY CAN BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY BROACH HIP INSTRUMENT/TRIAL KWA DEPUY INTERNATIONAL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention