BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG X3 INSERT 32MM HEAD

    MDR report key: 3781145 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01708
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    January 20, 2014
    Report Date
    April 17, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING INFECTION INVOLVING A TRIDENT 0 DEG X3 INSERT 32MM HEAD WAS REPORTED. THE EVENT WAS NOT CONFIRMED. 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. CONCLUSIONS: THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED AS PATIENT INFORMATION, CLINICAL HISTORY, AND RESULTS OF BLOODWORK FOR INFECTION WERE NOT PROVIDED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS MOST LIKELY A RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE IN THE HEALTHCARE FACILITY SETTING.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ADDED IN THIS REPORT: SIZE 4 ACCOLADE II 132 DEG; CAT# 6720-0435; LOT# 44765403, 32MM +8 V40 TAPER VIT HEAD; CAT# 6260-5-332; LOT# 42650403, PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM; CAT# 502-03-52D; LOT# MMPRJJ, 5.5 CANCELLOUS BONE SCREW 30MM; CAT# 2029-5530-1; LOT# MMNV21, 5.5 CANCELLOUS BONE SCREW 25MM; CAT# 2029-5525-1; LOT# MMNL2P. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AS IT WAS NOT SAVED AFTER EXPLANTATION. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED, BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED TO THE MANUFACTURER

    Description of Event or Problem · 1

    INFECTED TOTAL HIP REPLACEMENT. RIGHT SIDE. IMPLANTS REMOVED AND BIOMETRIC ANTIBIOTIC SPACER WAS IMPLANTED. WAS NOT MADE AWARE AT TIME OF EXPLANATION. TODAY, (B)(6) 2014 IS REVISION IMPLANTATION.

    Description of Event or Problem · 1

    INFECTED TOTAL HIP REPLACEMENT. RIGHT SIDE. IMPLANTS REMOVED AND BIOMETRIC ANTIBIOTIC SPACER WAS IMPLANTED. WAS NOT MADE AWARE AT TIME OF EXPLANATION. TODAY, (B)(6) 2014 IS REVISION IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259610 TRIDENT 0 DEG X3 INSERT 32MM HEAD IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MMP7H7

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention