BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11/13 S-ROM 40MM M SPEC+9

    MDR report key: 3063605 · Received April 17, 2013

    Report

    Report Number
    1818910-2013-15499
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 29, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC 1818910
    Product Code
    JDI
    PMA / PMN Number
    K060031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING PART AND LOT NUMBER. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. 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 ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT CODES 2982973 AND 2926358 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.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, DIFFICULTY AMBULATING, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE PATIENT'S BLOOD, TISSUE, AND BONE. UPDATE: (B)(4) 2013- PFS AND MEDICAL RECORDS RECEIVED. PART/LOT WAS PROVIDED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, DIFFICULTY AMBULATING, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE PATIENT'S BLOOD, TISSUE, AND BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164108 11/13 S-ROM 40MM M SPEC+9 S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS JDI DEPUY ORTHOPAEDICS INC 1818910 2926358

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other