BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI DUR REG FLUTED STEM12X155MM

    MDR report key: 4221727 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04131
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K973164
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING CRACK/FRACTURE INVOLVING A TITANIUM STEM EXTENDER WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS NO ITEMS WERE RETURNED FOR REVIEW. -MEDICAL RECORDS RECEIVED AND EVALUATION: THE MEDICAL REVIEW INDICATED THAT THE ROOT CAUSE OF FAILURE IS RELATED TO PROCEDURE-RELATED FACTORS OF COMPONENT CHOICE UNDER CONDITIONS OF A SEVERE BONE DEFECT CONDITION AS CAUSED BY A PREVIOUS FAILURE OF THE PRIMARY KNEE DEVICE. IN THIS CASE AN OVERLOAD CONDITION WAS PRESENT AT THE FEMORAL MODULAR CONNECTION LEADING TO A FATIGUE FRACTURE REQUIRING REVISION SURGERY AS REPORTED. NO EVIDENCE FOR DEVICE-RELATED FACTORS ALTHOUGH NO IMPLANTS WERE RETURNED FOR ANALYSIS. FROM THE PATIENT-RELATED PERSPECTIVE, THERE IS LITTLE SPECIFIC INFORMATION. PATIENT ACTIVITY LEVEL WAS NOT AN ISSUE. AS SUCH THE FAILURE IS NOT DEVICE-RELATED BUT HAS A PROCEDURE-RELATED ROOT CAUSE OF FAILURE. -DEVICE HISTORY REVIEW: THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO VENDOR STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT BASED ON THE MEDICAL REVIEW, THE ROOT CAUSE WAS RELATED TO PROCEDURE-RELATED FACTORS OF COMPONENT CHOICE UNDER CONDITIONS OF A SEVERE BONE DEFECT CONDITION AS CAUSED BY A PREVIOUS FAILURE OF THE PRIMARY KNEE DEVICE. IN THIS CASE AN OVERLOAD CONDITION WAS PRESENT AT THE FEMORAL MODULAR CONNECTION LEADING TO A FATIGUE FRACTURE REQUIRING REVISION SURGERY AS REPORTED. NO EVIDENCE FOR DEVICE-RELATED FACTORS ALTHOUGH NO IMPLANTS WERE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED THAT THE CUSTOMER UNDERTOOK A REVISION OF A TOTAL KNEE REPLACEMENT ON (B)(6) 2014. A DECISION WAS TAKEN IN (B)(6) 2014 TO UNDERTAKE THE REVISION WHEN THE PATIENT PRESENTED WITH PAIN AND THE SURGEON SUSPECTED THAT THE IMPLANT MAY HAVE COME LOOSE. AN X-RAY TAKEN IN (B)(6) 2014 FOR THE PURPOSE OF PRE-OP PLANNING SHOWED THE FEMORAL COMPONENT (B)(4) HAD BECOME DETACHED FROM THE FEMORAL STEM (B)(4) . THE CUSTOMER REPORTED THAT ON EXPLANTATION THE STEM HAD ALLEGEDLY FRACTURED AT THE JUNCTION WITH THE FEMORAL COMPONENT.

    Description of Event or Problem · 1

    DETAILS OF THE PATIENT'S REVISION HISTORY HAVE BEEN AMENDED HERE BASED ON SUPPLEMENTARY INFORMATION RECEIVED FROM THE REPRESENTATIVE. THIS CASE REFERS TO A ALLEGED FRACTURE OF THE STEM FOLLOWING THE 2ND REVISION WHICH RESULTED IN A 3RD REVISION. THE PATIENT'S REVISION HISTORY IS AS FOLLOWS: PRIMARY SURGERY - PFC TOTAL KNEE - DATE UNKNOWN. THE 1ST REVISION TOOK PLACE IN 2002 IN WHICH A SCORPIO TS WAS IMPLANTED. THE EXACT DATE OF IMPLANTATION WILL BE CLARIFIED WITH THE SURGEON. (THE SUBJECT OF THIS PI). THE 2ND REVISION (NOTE: THIS IS THE FIRST STRYKER REVISION) TOOK PLACE ON (B)(6) 2005 - THE KNEE WAS REVISED TO AN MRH - (THE SUBJECT OF PI). THE 3RD REVISION (NOTE: THIS IS THE 2ND STRYKER REVISION) TOOK PLACE ON (B)(6) 2014 - A GMRS MRH - THIS IS AN INTEROPERATIVE EVENT IN WHICH THE BOSS OF THE BASEPLATE ALLEGEDLY DID NOT ALIGN PERFECTLY WITH THE STEM. PATIENT DETAILS: BORN 1936, AVERAGE BUILD, ACTIVITY LEVEL NORMAL FOR HIS AGE. NO SPECIFIC EVENTS OR TRAUMA REPORTED IN THE LEAD UP TO THIS REVISION. THE CUSTOMER HAS REPORTED THAT THE SCORPIO TS PROCEDURE DID NOT HAPPEN AND THAT THE PFC WAS REPLACED BY AN MRH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702608 TI DUR REG FLUTED STEM12X155MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH TRN127B

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| O| R