BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRHK TIB INS 10MM XS/S S1/S2

    MDR report key: 4102970 · Received September 19, 2014

    Report

    Report Number
    0002249697-2014-03579
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    April 14, 2014
    Report Date
    August 30, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    PMA / PMN Number
    K994207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT # 64952020, LOT # S6YAN, DESCRIPTION: GMRS DIST FEM COMP SML R 65MM; CAT # 64812100, LOT # 052453 (AS REPORTED), DESCRIPTION: MRH TIB ROT COMP XS-XL; CAT # 5560-S-212, LOT # M8T6A, DESCRIPTION: TRI CEMENTED STEM 12MMX100MM; CAT # 64853113, LOT # 127567C, DESCRIPTION: MRS FEM STEM W/O BODY 13X127MM; CAT # 64812133, LOT # LDK499, DESCRIPTION: MRHK BUMPER INSERT 3 DEGREES. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING INFECTION INVOLVING AN MRH TIBIAL INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. 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 OR STERILE LOT REFERENCED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF THE REPORTED DEVICE, X-RAYS, OPERATIVE REPORTS AS WELL AS PATIENT HISTORY, FOLLOW-UP NOTES AND PATHOLOGY REPORTS ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS A KNOWN POSSIBLE ADVERSE OUTCOME OF SURGERY AND IS BEYOND STRYKER'S CONTROL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RIGHT TOTAL KNEE REVISION DUE TO INFECTION. I&D, FEMORAL, LINER AND MRH BUMPER EXCHANGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RIGHT TOTAL KNEE REVISION DUE TO INFECTION. I&D, FEMORAL, LINER AND MRH BUMPER EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584299 MRHK TIB INS 10MM XS/S S1/S2 IMPLANT KRO STRYKER ORTHOPAEDICS-MAHWAH LDN343

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R