BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG INSERT 36MM

    MDR report key: 3061574 · Received April 16, 2013

    Report

    Report Number
    0002249697-2013-01337
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 26, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K062419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE EVENT COULD NOT BE CONFIRMED. THE EXACT ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED DUE TO LIMITED INFORMATION PROVIDED. ADDITIONAL INFORMATION SUCH AS PATIENT MEDICAL RECORDS, X-RAYS AND THE EXPLANTED DEVICE WOULD BE NEEDED TO COMPLETE THE INVESTIGATION AND DETERMINE A ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: V40 COCR LFIT HEAD 36MM/+5, CAT# 6260-9-236, LOT# MKAD3R; 25MM MOD REV HIP BDY/BLT +10MMCOMPONENT LEVEL 9006-1-125, CAT# 6276-1-125, LOT# 40192401; BOWED CONICAL STEM 16 X 195MM RESTORATION MODULAR HIP SYSTEM, CAT# 6276-7-216, LOT# CAXMA36E; PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM, CAT# 502-03-52D, LOT# MLR7Y9; 6.5 CANCELLOUS BONE SCREW 20MM, CAT# 2030-6520-1, LOT# MHT276; 6.5 CANCELLOUS BONE SCREW 20MM, CAT# 2030-6520-1, LOT# MJRHTE; 6.5 CANCELLOUS BONE SCREW 35MM, CAT# 2030-6535-1, LOT# MLTTEY. 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. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT HAD A TOTAL RIGHT HIP REVISION (B)(6) 2013, 3 WEEKS POST OP GROSSLY INFECTED AND HAD TO REMOVE ALL COMPONENTS. NOTHING IMPLANTED AFTER REMOVAL.

    Description of Event or Problem · 1

    PATIENT HAD A TOTAL RIGHT HIP REVISION (B)(6) 2013, 3 WEEKS POST OP GROSSLY INFECTED AND HAD TO REMOVE ALL COMPONENTS. NOTHING IMPLANTED AFTER REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163756 TRIDENT 0 DEG INSERT 36MM IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MKRHNX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention