BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE

    MDR report key: 4281281 · Received November 26, 2014

    Report

    Report Number
    0001825034-2014-08813
    Event Type
    Injury
    Date Received
    November 26, 2014
    Report Date
    October 29, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WAS NOT PROVIDED FOR THE PATIENTS MENTIONED IN THE JOURNAL ARTICLE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "IMPROVED ACCURACY OF ALIGNMENT WITH PATIENT-SPECIFIC POSITIONING GUIDES COMPARED WITH MANUAL INSTRUMENTATION IN TKA¿ WHICH EXAMINED THE RELATIVE EFFECTIVENESS OF PSPGS AND MI IN ACHIEVING NEUTRAL MECHANICAL AXIS ALIGNMENT OF THE LOWER EXTREMITY AND OF THE FEMORAL AND TIBIAL COMPONENTS IN TWO GROUPS OF PATIENTS. THE FIRST GROUP OF PATIENTS (GROUP 1) CONSISTED OF FIVE-HUNDRED SIXTY-NINE (569) PATIENTS WHO UNDERWENT TOTAL KNEE ARTHROPLASTY PROCEDURES THAT UTILIZED PATIENT-SPECIFIC POSITIONING GUIDES (PSPG TKA). THE SECOND GROUP OF PATIENTS (GROUP 2) CONSISTED OF ONE-HUNDRED FIFTY-FIVE (155) PATIENTS WHO UNDERWENT TOTAL KNEE ARTHROPLASTY PROCEDURES THAT UTILIZED MANUAL INSTRUMENTATION (MI TKA). ALL PATIENTS UNDERWENT TOTAL KNEE ARTHROPLASTY PROCEDURES BETWEEN JUNE 2008 AND DECEMBER 2010. THE SURGERIES PERFORMED ON PATIENTS IN GROUP 1 IMPLEMENTED THE USE OF SIGNATURE KNEE GUIDES MANUFACTURED BY MATERIALISE NV. FOR ALL PATIENTS, THE ZONE IN WHICH THE OVERALL MECHANICAL AXIS PASSED THROUGH THE KNEE WAS ASSESSED. NEUTRAL ALIGNMENT WAS DEEMED TO BE 90° FOR THE INDIVIDUAL COMPONENTS AND THEIR RESPECTIVE MECHANICAL AXES AND 180° FOR THE FMA-TMA OR HIP-KNEE-ANKLE (HKA) ANGLE. ALL ANGLES ON THE LATERAL ASPECT OF THE INTERSECTING LINES WERE MEASURED, EXCEPT THE FAA-FMA ANGLE, WHICH WAS MEASURED AS THE MORE ACUTE ANGLE. ANGLES GREATER THAN AND LESS THAN NEUTRAL ALIGNMENT WERE DEEMED VARUS AND VALGUS, RESPECTIVELY. FOR THE HKA ANGLE AND BOTH COMPONENTS, THE MEAN INDIVIDUAL PATIENT ERROR FROM NEUTRAL ALIGNMENT WAS CALCULATED IN ADDITION TO THE ALL-PATIENT MEAN ANGULATION SINCE VARUS AND VALGUS ERRORS OFFSETTING ONE ANOTHER WOULD TEND TO NEUTRALIZE THE LATTER. THE USE OF PSPGS REDUCED THE PERCENTAGE OF HKA OUTLIERS AT RATES SUPERIOR TO MANY PREVIOUSLY REPORTED CAN (COMPUTER ASSISTED NAVIGATION) AND NEARLY ALL MI RATES. OUTLIERS FOR THE TIBIAL AND FEMORAL COMPONENT IN THIS STUDY FOR BOTH PSPG (10%, 22%) AND MI (7%, 18%) WERE LOWER THAN THOSE IN A META-ANALYSIS FOR MI (20%, 34%) BUT HIGHER THAN THOSE USING CAN (5%, 10%) [54]. THE MEAN POSTOPERATIVE FAA-FMA ANGLES FOR BOTH PSPG AND MI FELL WITHIN THE 5° TO 7° RANGE TYPICALLY ASSUMED FOR TKA PERFORMED USING INTRAMEDULLARY GUIDES AND WITHOUT PREOPERATIVE LLRS [22, 25]. FURTHER STUDIES ARE NECESSARY TO EXAMINE THE EFFECT OF COMPENSATORY OR COMPOUNDING EFFECTS OF INDIVIDUAL COMPONENT MALALIGNMENT ON THE OVERALL LOWER LIMB ALIGNMENT AND ON IMPLANT FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766932 UNKNOWN KNEE PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other