BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON INSERT PS#7 16MM

    MDR report key: 3120418 · Received May 20, 2013

    Report

    Report Number
    0002249697-2013-01701
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 5515-F-701 LOT # 3KCJ DESCRIPTION: TRIATHLON PS FEM COMP #7L-CEM; CAT # 5521-B-700 LOT # ZEOH DESCRIPTION: TRI TS BASEPLATE SIZE 7; CAT # 5560-S-112 LOT # M6C01EP DESCRIPTION: TRI CEMENTED STEM 12MMX50MM; CAT # 5551-G-381 LOT # 69P1 DESCRIPTION: TRIATHLON ASYMMETRIC X3 PATELLA. AT THIS TIME, IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A TRIATHLON TIBIAL INSERT WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS NO DEVICE WAS RETURNED. CLINICIAN REVIEW OF THE MEDICAL RECORDS PROVIDED CONCLUDED THAT (B)(6) BACTERIAL STRAINS OR ISSUES WITH PATIENT¿S IMMUNITY MAY HAVE BEEN PRESENT GIVEN THE PATIENT¿S PRIOR HISTORY WITH EPIDURAL ABSCESS AND (B)(6) INVOLVEMENT. ALSO FROM A PROCEDURAL PERSPECTIVE ARE SOME RISK FACTORS PRESENT TO INCREASE THE SUSCEPTIBILITY FOR INFECTION SUCH AS COMPLEX SURGERY AND MULTIPLE PREVIOUS SURGICAL PROCEDURES THAT WEAKEN THE QUALITY OF THE SKIN. AS SUCH, THIS PER CASE WAS CAUSED BY A MIX OF PATIENT-RELATED AND PROCEDURE-RELATED FACTORS. THERE ARE NO DEVICE-RELATED FACTORS EVIDENT IN THIS CASE AND THIS PER IS NOT DEVICE-RELATED. DHR REVIEW DETERMINED THAT THE LOT WAS MANUFACTURED AND PACKED TO SPECIFICATION. A REVIEW OF THE STERILIZATION RECORDS VERIFIED THE STERILITY OF THE REPORTED PRODUCT LOT. CHR REVIEW CONFIRMED THAT THERE HAVE BEEN NO SIMILAR EVENTS FOR THE LOT OR STERILE LOT. BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION CONCLUDED THAT THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS MANUFACTURING RELATED BUT RATHER RELATED TO A MIX OF PATIENT-RELATED AND PROCEDURE-RELATED FACTORS. IT IS NOTED THAT WHEN THE DOUBLE BARRIER PACKAGING IS OPENED, THE STERILITY OF ANY DEVICE BECOMES A FUNCTION OF HANDLING AND SURGICAL TECHNIQUE AND IS BEYOND STRYKER'S CONTROL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUBJECT WAS REVISED DUE TO INFECTION. THE X-RAYS WILL BE FORWARDED UPON RECEIPT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUBJECT WAS REVISED DUE TO INFECTION. THE X-RAYS WILL BE FORWARDED UPON RECEIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222583 X3 TRIATHLON INSERT PS#7 16MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LBT214

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention