BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 4175301 · Received October 15, 2014

    Report

    Report Number
    0002249697-2014-03890
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING AN UNKNOWN LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: THE DEVICE WAS NOT RETURNED, HOWEVER AN IMAGE WAS PROVIDED. DAMAGE WAS NOTED ON THE RIM OF THE INSERT MOST LIKELY DUE TO EXPLANTATION. MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT INFORMATION WAS RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW COULD NOT BE PERFORMED AS THE LOT ID IS UNKNOWN. COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS THE LOT ID IS UNKNOWN. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS RECEIVED. FURTHER INFORMATION SUCH AS DEVICE RETURN,ADDITIONAL X-RAYS, PATHOLOGY REPORT, AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. IF ADDITIONAL INFORMATION AND/OR THE DEVICE BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. THE CATALOG NUMBER AND LOT CODE OF THE REPORTED LINER WAS NOT PROVIDED. HOWEVER, DEVICE INFORMATION FOR THE OTHER DEVICES REPORTED WAS PROVIDED AND IS LISTED BELOW: CAT # 6021-0537, LOT # 31965602, DESCRIPTION: ACCOLADE PLUS TMZF HIP STEM #5, CAT # 502-11-56F, LOT # 3130601, DESCRIPTION: TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL, CAT # 6260-9-240, LOT # MHR13D, DESCRIPTION: V40 COCR LFIT HEAD 40MM/+4, UNKNOWN SCREW.

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER AND LOT CODE WERE NOT PROVIDED. THE DEVICE WAS DESCRIBED AS AN UNKNOWN LINER. THE OTHER DEVICES REFERENCED WERE: UNKNOWN ACCOLADE TMZF, UNKNOWN CUP, UNKNOWN HEAD. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED ON A RIGHT HIP DUE TO INFECTION. ALL IMPLANTS WERE EXPLANTED AND ANTIBIOTIC SPACER WAS PLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED ON A RIGHT HIP DUE TO INFECTION. ALL IMPLANTS WERE EXPLANTED AND ANTIBIOTIC SPACER WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654690 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R