BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO TS TIB INSERT

    MDR report key: 5063760 · Received September 9, 2015

    Report

    Report Number
    0002249697-2015-02951
    Event Type
    Injury
    Date Received
    September 9, 2015
    Date of Event
    August 12, 2015
    Report Date
    August 12, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K994128
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A SCORPIO INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS NO DEVICES WERE RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: NO PATIENT MEDICAL RECORDS WERE AVAILABLE FOR REVIEW. DEVICE HISTORY REVIEW: NOT PERFORMED AS NO LOT ID WAS PROVIDED FOR REVIEW. COMPLAINT HISTORY REVIEW: NOT PERFORMED AS NO LOT ID WAS PROVIDED FOR REVIEW. CONCLUSIONS: THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED AS PATIENT INFORMATION, CLINICAL HISTORY, AND RESULTS OF BLOODWORK FOR INFECTION WERE NOT PROVIDED. ADDITIONAL RECORDS SUCH AS X-RAYS, EXAMINATION OF THE EXPLANTED COMPONENTS, PRIMARY TOTAL KNEE OPERATIVE REPORT OR LIST OF PRIMARY COMPONENTS AVAILABLE ARE VITAL TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. THERE IS NO EVIDENCE THE PERIPROSTHETIC INFECTION WAS RELATED TO FACTORS OF FAULTY COMPONENT DESIGN, MANUFACTURING OR MATERIALS. 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. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT: #9 SCORPIO TS FEMUR; CAT# UNKNOWN; LOT# UNKNOWN; #9 SCORPIO TS BASEPLATE; CAT# UNKNOWN; LOT# UNKNOWN; #11 PATELLA; CAT# UNKNOWN; LOT# UNKNOWN; KMAX STEM EXTNDR(S,M,L,XL)40MM; CAT# 6476-8-250; LOT# UNKNOWN; 14MM PRESSFIT STEM; CAT# UNKNOWN; LOT# UNKNOWN; 10MM DISTAL FEMORAL BUILDUP; CAT# UNKNOWN; LOT# UNKNOWN; 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 DUE TO HOSPITAL POLICY. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    JRM RIGHT KNEE COMPONENTS EXPLANTED DUE TO INFECTION.

    Description of Event or Problem · 1

    JRM RIGHT KNEE COMPONENTS EXPLANTED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596677 SCORPIO TS TIB INSERT KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention