BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0° X3 INSERT 36MM ID

    MDR report key: 4123297 · Received September 26, 2014

    Report

    Report Number
    0002249697-2014-03642
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    July 16, 2013
    Report Date
    September 2, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT. NO.: 502-03-58F, PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 58MM, LOT CODE: MMHK17. CAT. NO.: 6570-0-136, DELTA V-40 CERAMIC HEAD 36/0, LOT CODE: 43865701. CAT. NO.: 6720-0635, SIZE 6 ACCOLADE II 132 DEG, LOT CODE: 43952104 . AT THIS TIME, IT CANNOT BE DETERMINED IF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A TRIDENT 0° X3 INSERT 36MM ID WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION. MEDICAL EVALUATION NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. DEVICE HISTORY REVIEW. INDICATED ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. COMPLAINT HISTORY REVIEW. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT OR STERILE LOT REFERENCED. THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED AS PATIENT INFORMATION, CLINICAL HISTORY, AND RESULTS OF BLOODWORK FOR INFECTION WERE NOT PROVIDED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    POSTOPERTIVE DIAGNOSIS: INFECTION FOLLOWING PRIMARY THA. EVERYTHING REMOVED: 1ST STAGE OF 2ND STAGE REVISION REVISION.

    Description of Event or Problem · 1

    POSTOPERATIVE DIAGNOSIS: INFECTION FOLLOWING PRIMARY THA. EVERYTHING REMOVED: FIRST STAGE OF 2ND STAGE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602498 TRIDENT 0° X3 INSERT 36MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MMJED1

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention