BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY 2.5 CVD 10MM INSERT

    MDR report key: 2163430 · Received June 24, 2011

    Report

    Report Number
    1818910-2011-11446
    Event Type
    Injury
    Date Received
    June 24, 2011
    Date of Event
    June 28, 2010
    Report Date
    September 13, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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 PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. THE PRODUCT CODE AND LOT CODE REQUIRED IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEWING AND SEARCHING THE COMPLAINT DATABASE WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE LACK OF THE PRODUCT TO EXAMINE AND INSUFFICIENT PRODUCT INFORMATION. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    ADVERSE EVENT OR PRODUCT PROBLEM FDA REPORT: PT HAD A TOTAL KNEE ARTHROPLASTY DONE IN (B)(6) 2009. THE ARTHROPLASTY HAS NEVER BEEN SATISFACTORY FOR HER AND HER DESCRIPTION OF ANTERIOR KNEE PAIN WITH ACTIVITY SUGGESTED ANTEROPOSTERIOR INSTABILITY OF THE JOINT. PHYSICAL EXAMINATION CONFIRMED A DEGREE OF ANTERIOR-POSTERIOR TRANSLATION AND TREATMENT WITH A POSTERIOR CRUCIATE LIGAMENT STABILIZING BRACE LED TO IMPROVEMENT IN HER SYMPTOMS. WE, THUS, HAVE OFFERED HER A REVISION KNEE REPLACEMENT TO REPLACE THE EXTERNAL BRACE PROVIDING STABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY 2.5 CVD 10MM INSERT TOTAL KNEE REPLACEMENT JWH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention