BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML 10.5 MMA 6.3 5/8 STD 12/14

    MDR report key: 2994212 · Received March 8, 2013

    Report

    Report Number
    1818910-2013-13435
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    PMA / PMN Number
    PK953694
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATION. THE STEM WAS FOUND TO BE IN A RETROVERTED POSITION WHICH WOULD BE CONSISTENT WITH DISLOCATIONS. THE STEM WAS ALSO LOOSE. DOI 10 YRS AGO - DOR (B)(6) 2013 (RIGHT HIP). UPDATE 03/27/2013 - PATIENT'S REVISION OPERATIVE RECORDS WERE RECEIVED. RECORDS CANNOT CONFIRM THE PATIENT'S DISLOCATIONS WERE ATTRIBUTED TO A LOOSE FEMORAL STEM. ALSO NOTED UPON REVISION WAS A PSEUDO-CAPSULE. THE HEAD AND LINER ARE BEING ADDED TO THE COMPLAINT. 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 RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. OPERATIVE NOTES WERE OBTAINED. REVIEW OF THE RECORDS DID NOT CONCLUSIVELY IDENTIFY A ROOT CAUSE FOR THE REPORTED DISLOCATIONS. 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.

    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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATION. THE STEM WAS FOUND TO BE IN A RETROVERTED POSITION WHICH WOULD BE CONSISTENT WITH DISLOCATIONS. THE STEM WAS ALSO LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100051 AML 10.5 MMA 6.3 5/8 STD 12/14 FEMORAL HIP STEM LPH DEPUY ORTHOPAEDICS, INC. 1818910 Y37FE1

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention