BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRHK TIB INS 10MM XS/S S1/S2

    MDR report key: 14073776 · Received April 11, 2022

    Report

    Report Number
    0002249697-2022-00507
    Event Type
    Injury
    Date Received
    April 11, 2022
    Date of Event
    March 16, 2022
    Report Date
    December 12, 2022
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    UDI-DI
    07613327043785
    PMA / PMN Number
    K994207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: 64811110, MRH KNEE FEM S LFT, LOT A434D, 64786625, TI DUR REG FLUTED STEM 15X80MM, LOT 101168, B000-0240 ,MD.UNIVERSAL CEMENT RESTRICTOR , LOT 6M9974, 64812110, MRHK FEMORAL BUSHING ,QTY 2 , LOT LKF396, 64812100 ,MRH TIB ROT COMP XS-XL , LOT 172811A, 64812120, MRH AXLE, LOT CTD48225, 64812130 ,MRHK BUMPER INSERT - NEUTRAL , LOT LKF417, 6495-5-011, 11MM PRESS FIT FLUTED STEM, LOT 204301C, 64953102 ,GMRS PROXIMAL TIBIAL STANDARD, LOT 154830A, 64812140 ,MRHK TIBIAL SLEEVE, LOT LKE108, UNKNOWN, 210-004-000 FEMORAL CANAL BRUSH FOR USE WITH INTERPULSE,AND LOT 20051012. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING INFECTION INVOLVING A MRH INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED THE FOLLOWING: "IT IS CONFIRMED THAT A 13-YEAR-OLD JORDANIAN ARAB FEMALE UNDERWENT A LIMB SALVAGE SURGERY WITH SUBSEQUENT LIMB SELVAGE SURGERY WITH A STRYKER ROTATING HINGE MEGA PROSTHESIS. 3 WEEKS POST SUBSEQUENTLY THE SURGICAL WOUND DEHISCED AND GOT INFECTED. IT IS MY ASSESSMENT THAT THE STRYKER PROSTHESIS IS NOT THE CAUSE OF THIS COMPLICATION. LIMB SALVAGE SURGERY ITSELF CARRIES A HIGHER RATE OF INFECTION THAN A PRIMARY KNEE SURGERY. THIS IS FURTHER COMPLICATED BY ADJUVANT CHEMOTHERAPY WHICH CAN INTERFERE WITH OR DELAY WOUND HEALING. IN ADDITION CHEMOTHERAPY IT CAN CAUSE IMMUNOCOMPROMISE LEADING. TO GREATER RISK FOR INFECTION." PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT OR STERILE LOT REFERENCED. CONCLUSION: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED THE FOLLOWING: "IT IS CONFIRMED THAT A 13-YEAR-OLD JORDANIAN ARAB FEMALE UNDERWENT A LIMB SALVAGE SURGERY WITH SUBSEQUENT LIMB SELVAGE SURGERY WITH A STRYKER ROTATING HINGE MEGA PROSTHESIS. 3 WEEKS POST SUBSEQUENTLY THE SURGICAL WOUND DEHISCED AND GOT INFECTED. IT IS MY ASSESSMENT THAT THE STRYKER PROSTHESIS IS NOT THE CAUSE OF THIS COMPLICATION. LIMB SALVAGE SURGERY ITSELF CARRIES A HIGHER RATE OF INFECTION THAN A PRIMARY KNEE SURGERY. THIS IS FURTHER COMPLICATED BY ADJUVANT CHEMOTHERAPY WHICH CAN INTERFERE WITH OR DELAY WOUND HEALING. IN ADDITION CHEMOTHERAPY IT CAN CAUSE IMMUNOCOMPROMISE LEADING. TO GREATER RISK FOR INFECTION." ALL STRYKER PRODUCTS SOLD AS STERILE ARE VALIDATED TO A MINIMUM STERILITY ASSURANCE LEVEL SAL OF 10^-6 IN ACCORDANCE TO APPLICABLE ISO STANDARDS. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    A STANMORE PATIENT SPECIFIC PRESCRIPTION FORM WAS PROVIDED FOR THE PATIENT'S LEFT KNEE. NOTED ON THE FORM: "FOR INFECTED PROXIMAL TIBIA GMRS." PROPOSED DATE OF SURGERY IS (B)(6)2022.

    Description of Event or Problem · 0

    A STANMORE PATIENT SPECIFIC PRESCRIPTION FORM WAS PROVIDED FOR THE PATIENT'S LEFT KNEE. NOTED ON THE FORM: "FOR INFECTED PROXIMAL TIBIA GMRS." PROPOSED DATE OF SURGERY IS (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1900484 MRHK TIB INS 10MM XS/S S1/S2 PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH 6481-3-210 LJP797 07613327043785

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female Hospitalization| R