BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 16B-LRG

    MDR report key: 2896806 · Received January 4, 2013

    Report

    Report Number
    1818910-2013-10267
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    December 20, 2012
    Report Date
    April 23, 2015
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    LPH
    PMA / PMN Number
    PK934412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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

    PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AND SLEEVE, WHICH HAD LITTLE TO NO BONE IN-GROWTH. OSTEOLYSIS WAS ALSO REPORTED. DOI (B)(6) 2005 - DOR (B)(6) 2012 (RIGHT HIP). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. C. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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 OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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

    PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AND SLEEVE, WHICH HAD LITTLE TO NO BONE INGROWTH. OSTEOLYSIS WAS ALSO REPORTED.

    Description of Event or Problem · 1

    UPDATE 4/23/2015 - PFS RECEIVED. PFS ALLEGES PAIN, TROUBLE WALKING, AND DIFFICULTY WITH DAILY ACTIVITIES. AFTER REVIEW OF THE PFS FOR MDR REPORTABILITY, THERE IS NO NEW INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 5/13/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4924 S-ROM*SLEEVE PRX ZTT, 16B-LRG FEMORAL HIP STEM ACCESSORY LPH DEPUY IRELAND 9616671 1160909

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention