BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*LINER 28MM/ 54-58MM,10 DEG

    MDR report key: 2925317 · Received January 22, 2013

    Report

    Report Number
    1818910-2013-11310
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK873585
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS AND POLY WEAR. LOOSENING OF THE STEM AT THE CEMENT/BONE INTERFACE WAS ALSO REPORTED; HOWEVER, COMPETITOR CEMENT WAS USED AT THE TIME OF ORIGINAL IMPLANTATION. DOI 1997 - DOR (B)(6) 2013 (HIP). THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODE REQUIRED WAS NOT PROVIDED. 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 WITHOUT DEVICE EXAMINATION. HOWEVER ALTHOUGH NOT RETURNED, IT WOULD NOT BE UNREASONABLE TO FIND POLY MATERIAL WEAR AFTER THE LENGTH OF TIME REPORTED AS IMPLANTED. BASED ON THE INVESTIGATION THE NEED FOR CORRECTIVE ACTION IS 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 WAS REVISED TO ADDRESS OSTEOLYSIS AND POLY WEAR. LOOSENING OF THE STEM AT THE CEMENT/BONE INTERFACE WAS ALSO REPORTED; HOWEVER, COMPETITOR CEMENT WAS USED AT THE TIME OF ORIGINAL IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28896 PFC*LINER 28MM/ 54-58MM,10 DEG ACETAUBLAR LINER JDI DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention