BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 18D-SML

    MDR report key: 2955114 · Received February 11, 2013

    Report

    Report Number
    1818910-2013-12145
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 27, 2013
    Manufacturer
    DEPUY IRELAND ¿ REG. # 9616671
    Product Code
    LPH
    PMA / PMN Number
    PK934412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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

    THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER RELATED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE FOR THE STEM, HEAD, OR LINER AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. MEDICAL RECORDS WERE OBTAINED. A REVIEW OF THE MEDICAL RECORDS DID NOT IDENTIFY A ROOT CAUSE OR PRODUCT ERROR. BASED ON THE INABILITY TO IDENTIFY 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59046 S-ROM*SLEEVE PRX ZTT, 18D-SML FEMORAL HIP STEM ACCESSORY LPH DEPUY IRELAND ¿ REG. # 9616671 2531754

    Patients

    Seq Age Sex Outcome Treatment
    1 83 HR Required Intervention