BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TIBIAL COMPONENT

    MDR report key: 7536335 · Received May 23, 2018

    Report

    Report Number
    3002806535-2018-00861
    Event Type
    Injury
    Date Received
    May 23, 2018
    Report Date
    May 23, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A. M. LEENDERS, M. G. M. SCHOTANUS, R. J. P. WIND, R. A. P. BORGHANS, N. P. KORT,¿A HIGH RATE OF TIBIAL PLATEAU FRACTURES AFTER EARLY EXPERIENCE WITH PATIENT-SPECIFIC INSTRUMENTATION FOR UNICOMPARTMENTAL KNEE ARTHROPLASTIES¿. KNEE SURGERY, SPORTS TRAUMATOLOGY, ARTHROSCOPY(2018) , HTTPS://DOI.ORG/10.1007/S00167-018-4956-9. (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BASED ON JOURNAL ARTICLE ENTITLED "A HIGH RATE OF TIBIAL PLATEAU FRACTURES AFTER EARLY EXPERIENCE WITH PATIENT-SPECIFIC INSTRUMENTATION FOR UNICOMPARTMENTAL KNEE ARTHROPLASTIES" BY LEENDERS, A. M. ET AL. (2018) ABSTRACT. PURPOSE PATIENT-SPECIFIC INSTRUMENTATION (PSI) FOR UNICOMPARTMENTAL KNEE ARTHROPLASTY (UKA) HAS BEEN AVAILABLE FOR A FEW YEARS. HOWEVER, LIMITED LITERATURE IS AVAILABLE ON THIS SUBJECT. HENCE, THE AIM OF THIS COHORT STUDY IS TO EVALUATE THE 2 YEARS¿ RESULTS OF OUR FIRST EXPERIENCES WITH THE USE OF PSI IN UKA. IT IS HYPOTHESISED THAT THERE IS NO ADVANTAGE IN RATE OF ADVERSE EVENTS AND IN RADIOLOGICAL AND FUNCTIONAL OUTCOMES IN COMPARISON TO LITERATURE ON THE CONVENTIONAL METHOD. METHODS . THIS COHORT INCLUDED 129 KNEES OF 122 PATIENTS, OPERATED BY ONE SURGEON. OUTCOME MEASURES WERE THE RATE OF ADVERSE EVENTS (AES); IMPLANT POSITION AS DETERMINED ON RADIOGRAPHS; THE ACCURACY OF THE DEFAULT AND APPROVED PLANNING OF THE IMPLANT SIZES AND THE PATIENT-REPORTED OUTCOME MEASURES (PROMS) PREOPERATIVELY, AND AT 3, 12 AND 24 MONTHS, POSTOPERATIVELY. RESULTS. A TOTAL OF 6 (4.9%) AES WERE OBSERVED IN THIS STUDY, WITH 4 (3.3%) TIBIAL FRACTURES BEING THE MAIN COMPLICATION. THE MEAN POSTOPERATIVE BIOMECHANICAL AXIS WAS 176.4° AND IN THE MAJORITY OF CASES, THE RADIOGRAPHIC CRITERIA, AS DETERMINED BY THE MANUFACTURER, WERE MET. THE TIBIAL COMPONENT SHOWED 20 (16.4%) OUTLIERS IN THE SAGITTAL AND 3 (2.5%) OUTLIERS IN THE FRONTAL PLANE. THERE WERE NO OUTLIERS OF THE FEMORAL COMPONENT. FOR THE FEMORAL AND TIBIAL COMPONENTS, RESPECTIVELY, IN 125 (96.9%) AND 79 (61.7%) CASES, THERE WAS AN AGREEMENT BETWEEN APPROVED PLANNING AND IMPLANTED COMPONENT SIZE. ALL PROMS IMPROVED SIGNIFICANTLY AFTER SURGERY. CONCLUSION. TIBIAL FRACTURE WAS THE MOST COMMON AE, PROBABLY RELATED TO THE TRANSITION FROM CEMENTED TO UNCEMENTED UKA. PERIOPERATIVE MODIFICATIONS TO THE SURGICAL TECHNIQUE WERE MADE IN ORDER TO PREVENT THIS AE. IMPROVEMENTS SHOULD BE MADE TO THE OPERATION TECHNIQUE OF THE UNCEMENTED TIBIAL PLATEAU TO OBTAIN AN ADEQUATE PLACEMENT AND AT THE SAME TIME REDUCE THE RISK FOR TIBIAL FRACTURE. THE PSI TECHNIQUE WAS A RELIABLE TOOL FOR THE PLACEMENT OF THE FEMORAL COMPONENT. FUNCTIONAL OUTCOME WAS IN LINE WITH LITERATURE ON THE CONVENTIONAL METHOD. IT IS STRONGLY RECOMMENDED THAT THE SURGEON APPROVES EVERY PREOPERATIVE PLAN, IN ORDER TO OPTIMISE THE ACCURACY DURING THE PSI SURGERY. THIS COMPLAINT REFERS TO ONE REVISIONS DUE TO TIBIAL PLATEAU FRACTURE (TABLE 3, DISCUSSION SECTION), OPEN REDUCTION INTERNAL FIXATION (ORIF) WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378447 UNKNOWN TIBIAL COMPONENT JWH BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R