BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 3781208 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01651
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). AN EVENT REGARDING INFECTION INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS CONFIRMED. VISUAL INSPECTION WAS PERFORMED ON PHOTOGRAPHS PROVIDED. THE INSERT APPEARS TO SHOW SOME PITTING AND SCRATCHES ON THE BEARING SURFACE CONSISTENT WITH CLINICAL USE, BUT APPEARS OTHERWISE UNREMARKABLE. MEDICAL RECORDS RECEIVED AND EVALUATION: NO RESULTS OR OUTCOME INFORMATION AVAILABLE. IN THIS CASE NO CORRELATION BETWEEN ANY SPECIFIC DEVICE PROPERTY AND INFECTION CAN BE ESTABLISHED. AS SUCH, THIS PI CASE IS CAUSED BY A MIX OF PATIENT-RELATED (MORBID OBESITY) AND PROCEDURE-RELATED FACTORS (TYPICAL HOSPITAL ACQUIRED INFECTION). ALSO THE FACT THAT A (B)(6) STRAIN WAS PRESENT POINTS TO A CLINICAL/HOSPITAL ORIGIN OF THE INFECTION. DEVICE HISTORY REVIEW: THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT AND STERILE LOT REFERENCED. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE REPORTED INFECTION WAS CAUSED BY A MIX OF PATIENT-RELATED (MORBID OBESITY) AND PROCEDURE-RELATED FACTORS (TYPICAL HOSPITAL ACQUIRED INFECTION). ALSO THE FACT THAT A (B)(6) STRAIN WAS PRESENT POINTS TO A CLINICAL/HOSPITAL ORIGIN OF THE INFECTION.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT. NO.: 5520-B-500, TRIATHLON PRIM CEM FXD BPLT #5, LOT CODE: S66FN; CAT. NO.: 5551-G-320, TRIATHLON ASYMMETRIC X3 PATELLA, LOT CODE: RKN5; CAT. NO.: 5515-F-601, TRIATHLON PS FEM COMPONENT, CEMENTED, LOT CODE: GJEOD; CAT. NO.: 5551-G-320, TRIATHLON ASYMMETRIC X3 PATELLA, LOT CODE: RKN5. AT THIS TIME, IT CANNOT BE DETERMINED IF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. RETAINED AT (B)(6).

    Description of Event or Problem · 1

    THE ARTHROPLASTY WAS REVISED DUE TO INFECTION. THE COMPONENTS WERE IMPLANTED IN SITU FOR ~ 0 Y. THE TIBIAL AND FEMORAL COMPONENTS WERE REVISED.

    Description of Event or Problem · 1

    THE ARTHROPLASTY WAS REVISED DUE TO INFECTION. THE COMPONENTS WERE IMPLANTED IN SITU FOR ~ 0 Y. THE TIBIAL AND FEMORAL COMPONENTS WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260321 TRIATHLON PS X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MKRATV

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention