BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL ROTATING HINGE

    MDR report key: 9451447 · Received December 11, 2019

    Report

    Report Number
    3004105610-2019-00130
    Event Type
    Injury
    Date Received
    December 11, 2019
    Date of Event
    October 14, 2019
    Report Date
    February 7, 2020
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KRO
    PMA / PMN Number
    K121029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D6 DATE OF IMPLANT CORRECTED FROM (B)(6) 2015 TO (B)(6) 2006 ADDITIONAL MANUFACTURER NARRATIVE : REPORTED EVENT AN EVENT REGARDING CRACK/FRACTURE OF A TIBIAL HINGE INVOLVING A PATIENT SPECIFIC DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED BY MEDICAL REVIEW. METHOD AND RESULTS: PRODUCT EVALUATION AND RESULTS: NOT PERFORMED AS NO ITEMS WERE RETURNED. CLINICIAN REVIEW: THE IMPLANT IN SITU WAS FOR A PROXIMAL TIBIAL REPLACEMENT, WHICH WAS ORIGINALLY INSERTED IN 1994 AND SUBSEQUENTLY REVISED SEVERAL TIMES. THE SURGEON REPORTED THAT THE HINGE KNEE HAS BROKEN BUT THE FEMORAL AND TIBIAL STEMS ARE WELL FIXED. THE X-RAY PROVIDED SHOWED THAT THE STEM FOR THE ROTATING HINGE HAS BROKEN AT THE JUNCTION OF THE TIBIAL COMPONENT AND THE PIECE OF METAL CAN BE SEEN NEXT TO THE TIBIA COMPONENT. THE FEMORAL STEM IS WELL FIXED, HOWEVER THERE IS SOME BONE RESORPTION AND OSTEOLYSIS AT THE TIBIAL RESECTION LEVEL, BUT THIS SHOULD NOT BE RELATED TO THE REPORTED FRACTURE OF THE STEM OF THE HINGE. THEREFORE, THE RADIOGRAPHIC ASSESSMENT CAN CONFIRM THE REASON FOR REVISION. PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE 1 DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 11AUG2006 NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: BASED ON THE DEVICE IDENTIFICATION THE COMPLAINT DATABASES WERE REVIEWED FROM 01JAN2016 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING CRACK/FRACTURE OF THE TIBIAL HINGE INVOLVING A PATIENT SPECIFIC PROXIMAL TIBIA THERE HAS BEEN 1 OTHER EVENT. CONCLUSIONS: AN EVENT REGARDING CRACK/FRACTURE OF A TIBIAL HINGE INVOLVING A PATIENT SPECIFIC DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED BY MEDICAL REVIEW. THE IMPLANT WAS IN SITU FOR 13 YEARS. THE SURGEON ALSO REPORTED THAT THE PATIENT IS IN GOOD HEALTH CONDITION, ALTHOUGH NOT ABLE TO WALK WITHOUT CRUTCHES AND WITH LOWER LIMB ORTHOSIS. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION SUCH AS RETRIEVAL ANALYSIS ON THE EXPLANTED IMPLANT, THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND/OR INSUFFICIENT INFORMATION WAS RECEIVED BY SIW. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE RE-OPENED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE PATIENT WILL HAVE A REVISION DUE TO A BROKEN ROTATING HINGE. FEMORAL AND TIBIAL SHAFT COMPONENTS ARE STILL WELL FIXED. THE PATIENT HAS A GROSS CLINICAL INSTABILITY AND IS UNABLE TO WALK WITHOUT CRUTCHES AND LOWER LIMB ORTHOSIS. SO WE NEED TO CHANGE ONLY THE ROTATING HINGE. UPDATE 06JAN2020 - AS PER EMAIL, THE TIBIAL HINGED WAS NOT REVISED IN 2015 THEREFORE THE REPORTED FRACTURED TIBIAL HINGED IS FROM PIN 12321.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS BEING PERFORMED IN AN ATTEMPT TO IDENTIFY THE CAUSE OF THE EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PATIENT WILL HAVE A REVISION DUE TO A BROKEN ROTATING HINGE. FEMORAL AND TIBIAL SHAFT COMPONENTS ARE STILL WELL FIXED. THE PATIENT HAS A GROSS CLINICAL INSTABILITY AND IS UNABLE TO WALK WITHOUT CRUTCHES AND LOWER LIMB ORTHOSIS. SO WE NEED TO CHANGE ONLY THE ROTATING HINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246560 TIBIAL ROTATING HINGE PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STANMORE IMPLANTS WORLDWIDE PIN 12321 PIN 12321

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R