BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL AMT COLLAR SIZE 15

    MDR report key: 2232835 · Received August 18, 2011

    Report

    Report Number
    1818910-2011-13694
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    May 29, 2011
    Report Date
    July 20, 2011
    Manufacturer
    DEPUY FRANCE S.A.S. SAINT PRIEST
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A RECALL WAS PERFORMED IN 2004 CONCERNING CORAIL AMT STEMS.;THE REFERENCES CONCERNED BY THIS RECALL WERE THE FOLLOWING: 3L92498 TO 3L93716 AND (B)(4) TO (B)(4).THE BATCHES CONCERNED BY THIS RECALL WERE : ALL BATCHES LESS THAN 1391546. 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)/ (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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    NECK FRACTURE OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL AMT COLLAR SIZE 15 87 KWA, LZO, MEH, LWJ KWA DEPUY FRANCE S.A.S. SAINT PRIEST NA 1244328

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention