BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ROM M HEAD 36MM +6

    MDR report key: 2944932 · Received February 6, 2013

    Report

    Report Number
    1818910-2013-02160
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 15, 2013
    Report Date
    July 11, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    JDI
    PMA / PMN Number
    PK120599
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. THE COMPLAINT HAS BEEN REOPENED BECAUSE PRODUCT INFORMATION HAS BEEN RECEIVED WHICH MAY CHANGE THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. CLINICAL REPORT WAS RECEIVED. CLINICAL REPORT STATES THE PATIENT WAS REVISED TO ADDRESS METALLOSIS.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. 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 THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED OTHER REPORTS AGAINST THE METAL ON METAL ARTICULATING COMPONENTS. PER PROCEDURE, THESE DEVICES ARE EXEMPT FROM DEVICE HISTORY RECORD REVIEW. HOWEVER, A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. NO OTHER REPORTS FOUND AGAINST THE REMAINING PRODUCT/LOT CODE COMBINATION(S). XRAYS WERE REVIEWED. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. 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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. 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. 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 PAPERS ALLEGE: SUFFERED SEVERE PAIN AND DISCOMFORT. **UPDATE** - THE COMPLAINT HAS BEEN REOPENED BECAUSE IT HAS BEEN REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN ON (B)(6) 2013.

    Description of Event or Problem · 1

    UPDATE 2/24/2016, 2/26/2016, 2/29/2016 MEDICAL RECORDS RECEIVED. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. MEDICAL RECORDS REPORTED CUP TO BE SOMEWHAT VERTICAL AND ANTIVERTED, STEM APPEARED SLIGHTLY UNDERSIZED AND METAL STAINED FLUID COLLECTION AND TISSUES AT REVISION. LAB RESULTS FOR METAL IONS WERE GREATER THAN 7 PARTS PER BILLION. STEM WILL BE ADDED TO COMPLAINT FOR ELEVATED IONS AND CUP ADDED FOR MALPOSITION. THE COMPLAINT WAS UPDATED ON: MAR 8, 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50193 S-ROM M HEAD 36MM +6 FEMORAL HEAD JDI DEPUY INTERNATIONAL 2427283

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention