BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL AMT COLLAR SIZE 11

    MDR report key: 2923755 · Received January 22, 2013

    Report

    Report Number
    1818910-2013-11212
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 1, 2012
    Report Date
    January 9, 2013
    Manufacturer
    DEPUY FRANCE
    Product Code
    KWA
    PMA / PMN Number
    PK042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A RECALL WAS PERFORMED IN 2004 CONCERNING CORAIL AMT STEMS. THE REFERENCES CONCERNED BY THIS RECALL WERE THE FOLLOWING: (B)(4). THE BATCHES CONCERNED BY THIS RECALL WERE: ALL BATCHES LESS THAN (B)(4). THIS RECALL WAS PERFORMED BECAUSE THE CONCERNING PARTS WERE LASER ETCHED ON THE NECK AND SUBSEQUENTLY THERE WERE A RISK OF FRACTURE OF THE STEM. THE REFERENCE / BATCH INVOLVED IN THE CURRENT COMPLAINT ((B)(4)) IS PART OF THE BATCHES CONCERNED BY THE RECALL. AS A CONSEQUENCE, THE ROOT CAUSE OF THE NECK FRACTURE IS THE ETCHING LOCATED ON THE NECK. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    CORAIL NECK FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30790 CORAIL AMT COLLAR SIZE 11 HIP STEM KWA DEPUY FRANCE 1257850

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention