BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE METAL INSERT

    MDR report key: 1847345 · Received September 24, 2010

    Report

    Report Number
    1818910-2010-06897
    Event Type
    Injury
    Date Received
    September 24, 2010
    Report Date
    August 26, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    LPH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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

    DEPUY (B)(4) REPORTS: THE PATIENT WILL BE REVISED DUE TO PAIN. DOI: TWO YEARS AGO. TWO YEARS AGO, THA WAS DONE WITH MOM FOR THE OSTEOARTHRITIS OF THE HIP. ON (B)(6) 2010, THE PATIENT VISITED THE HOSPITAL BECAUSE OF PAIN. IT WAS NOTED THROUGH X-RAY THAT MILD OSTEOLYSIS WAS NOTED IN THE PROXIMAL PART OF THE STEM. NO STEM DISLOCATION WAS CONFIRMED. NO INFECTION WAS NOTED. PSEUDO TUMOR WAS SUSPECTED. CUP (P/C AND LOT UNKNOWN) WAS MANUFACTURED BY JMM. WE WILL LET YOU KNOW PRODUCT INFORMATION AS SOON AS POSSIBLE. THE DEVISES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVISE HISTORY RECORDS AND OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS UNAVAILABLE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. 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 AND / 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

    THE PATIENT WILL BE REVISED DUE TO PAIN. DOI: TWO YEARS AGO. TWO YEARS AGO, THA WAS DONE WITH MOM FOR THE OSTEOARTHRITIS OF THE HIP. THE PATIENT VISITED THE HOSPITAL BECAUSE OF PAIN. IT WAS NOTED THROUGH X-RAY THAT MILD OSTEOLYSIS WAS NOTED IN THE PROXIMAL PART OF THE STEM. NO STEM DISLOCATION WAS CONFIRMED. NO INFECTION WAS NOTED. PSEUDOTUMOR WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE METAL INSERT TOTAL HIP PROSTHESIS LPH DEPUY INTERNATIONAL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention