BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 24F-XXL

    MDR report key: 2758022 · Received September 25, 2012

    Report

    Report Number
    1818910-2012-21654
    Event Type
    Injury
    Date Received
    September 25, 2012
    Report Date
    August 31, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    K934412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING PART AND LOT NUMBER. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH 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 IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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 YX8LM1000, 2598626, 2358009, YK9EF1000, AND 1170026. A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODE 1218598 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE PART AND LOT CODE COMBINATION WAS NOT PROVIDED FOR THE BONE SCREW. MEDICAL RECORDS WERE RECEIVED AND REVIEWED. 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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT THE PATIENT WAS REVISED TWICE FOR PAIN AND DISCOMFORT.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT THE PATIENT WAS REVISED TWICE FOR PAIN AND DISCOMFORT. UPDATE: (B)(4) 2012 - PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS INDICATE THAT (B)(6) 2004 PRIMARY IMPLANT; (B)(6) 2008 HIP WAS ASPIRATED, NO INFECTION FOUND, NOTHING REMOVED; (B)(6) 2009 REVISED FOR PAIN AND LOOSE STEM; (B)(6) 2010 HIP WAS ASPIRATED, NO INFECTION FOUND, NOTHING REMOVED; (B)(6) 2010 REVISED FOR LOOSE STEM, SLEEVE, CUP HAD NO BONY INGROWTH, BROKEN SCREW, POSSIBLE INFECTION. ALL PRODUCTS REMOVED ANTIBIOTIC SPACER PLACED. (B)(6) 2011 ANTIBIOTIC SPACER REMOVED, RE-IMPLANTED WITH COMPETITOR PRODUCT. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-ROM*SLEEVE PRX ZTT, 24F-XXL HIP LINER LPH DEPUY ORTHOPAEDICS INC US 2358009

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other| R