BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYLAMER 10D 54OD X 28ID

    MDR report key: 2093689 · Received May 12, 2011

    Report

    Report Number
    1818910-2011-08559
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    June 8, 2006
    Report Date
    April 12, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K944538
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. PRE AND POST OPERATIVE NOTES RECEIVED AND REVIEWED. NO INDICATIONS IN THE REVISION SURGERY NOTES OR THE NOTES FOLLOWING THAT THE PATIENTS CURRENT PAIN IS PRODUCT RELATED. 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

    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 REVISED FOR DISLOCATION OF RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYLAMER 10D 54OD X 28ID 87 HRY, HSX, JDB, JDI, JWH, KWA, KWT LPH DEPUY ORTHOPAEDICS, INC. NA 584380034

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention