BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPHERE M SPEC 12/14 36 +5

    MDR report key: 3100268 · Received May 8, 2013

    Report

    Report Number
    1818910-2013-16787
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    May 25, 2010
    Report Date
    April 8, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    PK082585
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES D2CHJ1000, DW3CG1000, DY5KN4000, AND DS1GJ4000. A SEARCH OF THE COMPLAINT DATABASE SEARCH FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODE 2920877 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT FACT SHEET AND MEDICAL RECORDS RECEIVED. OPERATIVE NOTES INDICATED INFECTION. ALL PRODUCTS HAVE BEEN REPORTED. UPDATE (B)(4) 2013- LITIGATION PAPERS RECEIVED. LITIGATION MENTIONED SEVERAL OTHER DATES OF REVISION. WE WERE UNAWARE OF, IF ANY, DEPUY PRODUCT WAS IMPLANTED/REVISED DURING THESE SURGERIES. OPERATIVE NOTES HAVE NOW INDICATED THAT DEPUY PRODUCT WAS INVOLVED IN THESE SURGERIES. ALL APPROPRIATE UPDATES HAVE BEEN MADE.

    Description of Event or Problem · 1

    IN ADDITION TO WHAT PREVIOUSLY ALLEGED, PPF CONSTRAINED LINER, LOOSENING OF CUP, LOOSENING OF STEM. ADDED ALL PRODUCTS OF (B)(6) 2009. UPDATED PATIENT'S IDENTIFIER, PATIENT HARM. ADDED PATIENT'S AGE, EXPIRATION DATE OF THE HEAD, REVISION HOSPITAL, REVISION SURGEON, LAWYER IN THE ASSOCIATED CONTACT AND LAW FIRM IN THE FACILITY NAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201288 ASPHERE M SPEC 12/14 36 +5 FEMORAL HEAD KWA DEPUY ORTHOPAEDICS INC US 2920877

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| R