BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM M HEAD 36MM +3

    MDR report key: 3328093 · Received September 5, 2013

    Report

    Report Number
    1818910-2013-26426
    Event Type
    Injury
    Date Received
    September 5, 2013
    Report Date
    November 9, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    PK851422
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT CODES 2061463 AND 2272157 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

    UPDATE: (B)(4) 2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. PATIENT DEMOGRAPHICS ADDED.

    Description of Event or Problem · 1

    THE PATIENT HARM WAS UPDATED AND ADDED DATE OF REVISION, PRODUCT EXPERIENCE CODE, SURGEON, HOSPITAL NAME, AND EXPIRATION DATE OF METAL LINER AND METAL HEAD. THE STEM, SLEEVE AND THE UNKNOWN HIP IMPLANT WERE ADDED TO THE IMPACTED PRODUCT DUE TO ALLEGES LOOSENING OF STEM AND FRACTURE COMPONENT FROM THE PPF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442494 S-ROM M HEAD 36MM +3 FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 2272157

    Patients

    Seq Age Sex Outcome Treatment
    1