BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 18F-LRG

    MDR report key: 2992584 · Received March 7, 2013

    Report

    Report Number
    1818910-2013-13347
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    9616671 DEPUY (IRELAND)
    Product Code
    LPH
    PMA / PMN Number
    PK934412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE PATIENT WAS REVISED BECAUSE OF LOOSENING OF THE STEM AND SLEEVE. UPDATE 03/21/2013 - PATIENT'S OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION THE POLY WAS NOTED TO BE WORN. THE LINER WAS ADDED TO THE COMPLAINT. DOI: (B)(6) 2000 DOR: (B)(6) 2013 (RIGHT HIP). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. X-RAYS WERE OBTAINED WITH THE COMPLAINT. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. OPERATIVE NOTES WERE THEN RECEIVED. 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. 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

    THE PATIENT WAS REVISED BECAUSE OF LOOSENING OF THE STEM AND SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97960 S-ROM*SLEEVE PRX ZTT, 18F-LRG SROM SLEEVE LPH 9616671 DEPUY (IRELAND) 675129

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention