BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY FEMORAL

    MDR report key: 1040129 · Received May 7, 2008

    Report

    Report Number
    1818910-2008-01446
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 10, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HSA
    PMA / PMN Number
    K950010
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE EXACT DATE OF THE PRIMARY SURGERY IS UNKNOWN, IT WAS REPORTED TO HAVE OCCURRED APPROXIMATELY TWO YEARS AGO. EXAMINATION WAS NOT POSSIBLE, AS NO PRODUCT WAS RETURNED. A SEARCH OF THE WARSAW AND INTERNATIONAL COMPLAINT DATABASE DID NOT FIND ANY ADDITIONAL REPORTS OF THIS NATURE FOR THE PRODUCT CODE/LOT PROVIDED SINCE ITS RESPECTIVE RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. THE INITIAL REPORT STATES THAT IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE 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 TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    UPDATE 6/2/2011 - THE MANUFACTURER OF THE CEMENT USED AT THE PRIMARY SURGERY WAS IDENTIFIED AS DEPUY CEMENT. DOI: (B)(6) 2007 (LEFT SIDE). DEPUY (B)(4) WAS UNABLE TO RETEST THE RETAINED SAMPLE OF THIS PRODUCT, AS IT IS MANUFACTURED IN 2006 AND HAS EXPIRED RETENTION, IN ACCORDANCE WITH THE QUALITY RETAINED SAMPLE PROCEDURE (B)(4). REVIEW OF THE DHR CONFIRMED THAT ALL QC AND MICROBIOLOGICAL RESULTS COMPLIED WITH SPECIFICATIONS PRIOR TO RELEASE OF THE PRODUCT. THERE WERE NO ANOMALIES WITH THE STERILIZATION OF THIS LOT. WITHOUT A RETAINED SAMPLE TO TEST NO CONCLUSIVE ROOT CAUSE CAN BE IDENTIFIED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN ATTRIBUTED TO LOOSENING OF THE FEMORAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY FEMORAL TOTAL KNEE REPLACEMENT HSA DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention