BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO PS FEMUR M/S W/POSTS LFIT

    MDR report key: 3984262 · Received August 6, 2014

    Report

    Report Number
    0002249697-2014-03033
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    January 1, 2006
    Report Date
    July 18, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K033972
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING PAIN INVOLVING A SCORPIO FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT INFORMATION WAS RECEIVED FOR REVIEW. DEVICE HISTORY REVIEW: THE REPORTED DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED PAIN MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CATALOG: 72-15-0710, DESCRIPTION: SCORPIOFLEX TOTAL KNEE PS, SHC, LOT: 17259001. AN EVENT REGARDING PAIN INVOLVING A SCORPIO FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE MEDICAL RECORDS BY THE CONSULTING CLINICIAN INDICATED "ON AN OFFICE VISIT OF (B)(6) 2014 SHE COMPLAINED OF LEFT HIP PAIN, WHICH WAS CONSTANT SIX OVER TEN PAIN INCREASED WITH WALKING. EXAMINATION OF THE KNEES REVEALED A ¿FULL RANGE OF MOTION, NO TENDERNESS, NO EFFUSION, NO CREPITUS, NO WEAKNESS...X-RAY PRINTOUTS AVAILABLE FOR REVIEW INCLUDE A SERIES DATED (B)(6) 2007, WHICH IS AN AP OF BOTH KNEES, DEMONSTRATING A CEMENTED TIBIAL COMPONENT AND STEM OF THE RIGHT TOTAL KNEE ARTHROPLASTY IN NOMINAL POSITION AND AN OSTEOARTHRITIC LEFT KNEE...THE IMPLANTS USED IN THIS CASE WERE NOT SUBJECT TO A RECALL." CONCLUSIONS: THE ROOT CAUSE COULD NOT BE DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. A REVIEW OF THE MEDICAL RECORDS BY THE CONSULTING CLINICIAN INDICATED "ON AN OFFICE VISIT OF (B)(6) 2014 SHE COMPLAINED OF LEFT HIP PAIN, WHICH WAS CONSTANT SIX OVER TEN PAIN INCREASED WITH WALKING. EXAMINATION OF THE KNEES REVEALED A ¿FULL RANGE OF MOTION, NO TENDERNESS, NO EFFUSION, NO CREPITUS, NO WEAKNESS...X-RAY PRINTOUTS AVAILABLE FOR REVIEW INCLUDE A SERIES DATED (B)(6) 2007, WHICH IS AN AP OF BOTH KNEES, DEMONSTRATING A CEMENTED TIBIAL COMPONENT AND STEM OF THE RIGHT TOTAL KNEE ARTHROPLASTY IN NOMINAL POSITION AND AN OSTEOARTHRITIC LEFT KNEE...THE IMPLANTS USED IN THIS CASE WERE NOT SUBJECT TO A RECALL." A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED PAIN MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT. NO.: 6197-9-001, SIMPLEX P WITH TOBRAMYCIN 1 PACK, LOT CODE: MCN010. CAT. NO.: 6476-8-250, KMAX STEM EXTNDR(S,M,L,XL)40MM , LOT CODE: LCM600. CAT. NO.: 7650-2038, STERILE HEADLESS 1/8" PIN, LOT CODE: 37964802. CAT. NO.: 77-4007, SCORPIO TS MOD. TIB. TRAY, LOT CODE: JP8MHA. CAT. NO.: 73-3308, SCORPIO U-DOME PATELLA , LOT CODE: 11EGLAX1. 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. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    PATIENT REPORTS HAVING PAIN IN RIGHT KNEE SINCE PRIMARY SURGERY.

    Description of Event or Problem · 1

    PATIENT REPORTS HAVING PAIN IN RIGHT KNEE SINCE PRIMARY SURGERY.

    Description of Event or Problem · 1

    PATIENT REPORTS HAVING PAIN IN RIGHT KNEE SINCE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461579 SCORPIO PS FEMUR M/S W/POSTS LFIT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH STRYKER ORTHOPAEDICS-MAHWAH K03T111

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other