BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMRS TIBIAL INSERT SMALL 13MM

    MDR report key: 3714139 · Received March 31, 2014

    Report

    Report Number
    0002249697-2014-00971
    Event Type
    Injury
    Date Received
    March 31, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 5, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    PMA / PMN Number
    K023087
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION CAT # 6485-3-815 REVISED TO CAT # 64952030. THE PATIENT IS 63 INCHES IN HEIGHT. AN EVENT REGARDING INFECTION INVOLVING A GMRS TIBIAL INSERT SMALL 13MM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: THE PROVIDED MEDICAL INFORMATION WAS SUBMITTED TO A CONSULTING CLINICIAN WHO DEEMED IT INSUFFICIENT FOR A MEDICAL REVIEW. THE REPORTED EVENT COULD NOT BE CONFIRMED WITH THE PROVIDED X-RAYS. 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 THE PROVIDED MEDICAL INFORMATION SUBMITTED TO THE CONSULTING CLINICIAN WAS DEEMED INSUFFICIENT FOR A MEDICAL REVIEW. ADDITIONAL PATIENT INFORMATION, MEDICAL RECORDS, CLINICAL HISTORY, AND RESULTS OF BLOODWORK FOR INFECTION ARE REQUIRED FOR DETERMINING ROOT CAUSE. 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

    ADDITIONAL DEVICES LISTED IN THIS REPORT:CAT 6485-3-815, LOT EC8XN, DESCRIPTION: MRS CVD FEM ST W/O BODY 15X127.CAT 6481-2-120, LOT CTD2328, DESCRIPTION: MRH AXLE.CAT 6481-2-133, LOT IDF121, DESCRIPTION: MRHK BUMPER INSERT 3 DEGREES.CAT 6481-2-150, LOT LDI196, DESCRIPTION: MRH HDP ASSEMBLY PACK.CAT 6495-3-601, LOT 043229, DESCRIPTION: GMRS TIB ROTATING SML COMP.IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENTS' EXPERIENCE. IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PATIENT'S KNEE STARTED DRAINING. DOCTOR OPENED KNEE COMPLETED A CULTURE AND A FROZEN SECTION. THE DOCTOR WASHED THE SURGICAL SITE AND REPLACED SOME IMPLANTS. NO UNUSUAL CIRCUMSTANCES.

    Description of Event or Problem · 1

    THE PATIENT'S KNEE STARTED DRAINING. DOCTOR OPENED KNEE COMPLETED A CULTURE AND A FROZEN SECTION. THE DOCTOR WASHED THE SURGICAL SITE AND REPLACED SOME IMPLANTS. NO UNUSUAL CIRCUMSTANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188835 GMRS TIBIAL INSERT SMALL 13MM IMPLANT KRO STRYKER ORTHOPAEDICS-MAHWAH LCR272

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Congenital Anomaly| H| O| S