BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG INSERT 36MM

    MDR report key: 2941850 · Received February 4, 2013

    Report

    Report Number
    0002249697-2013-00539
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K062419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 6364-2-136 LOT # G3279924 DESCRIPTION: V40(TM). FEMORAL HEAD. CAT # 540-11-48D LOT # PDDMKD DESCRIPTION: TRIDENT PSL HA SOLID BACK 48MM. CAT # 0580-1-351 LOT # G1547476 DESCRIPTION: EXETER V40 STEM 35.5MM. CAT # 0939-0-112 LOT # L3167A DESCRIPTION: EXETER 2.5 I M PLUG 12MM. CAT # 6197-9-001 LOT # MFT054 DESCRIPTION: SIMPLEX P WITH TOBRAMYCIN 1 PACK. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    PATIENT MEDICAL RECORDS WERE PROVIDED AND UPON REVIEW BY A CONSULTING CLINICIAN, WHO CONCLUDED THE FOLLOWING: THERE IS NO EVIDENCE THAT FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS WERE RESPONSIBLE FOR THIS INFECTED RIGHT HYBRID TOTAL HIP ARTHROPLASTY. THE EVENT WAS CONFIRMED. DHR INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. FURTHERMORE, A REVIEW OF THE STERILIZATION RECORDS VERIFIED THE STERILITY OF THE REPORTED PRODUCT LOTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD INITIAL SURGERY(B)(6) 2007, ON (B)(6) 2012, THE PATIENT WAS INFECTED AND RECEIVED A WASHOUT AND PUT IN CEMENT ANTIBIOTIC SPACER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD INITIAL SURGERY (B)(6) 2007, ON (B)(6) 2012 THE PATIENT WAS INFECTED AND RECEIVED A WASHOUT AND PUT IN CEMENT ANTIBIOTIC SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46979 TRIDENT 0 DEG INSERT 36MM IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MKRWY5

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention