BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE

    MDR report key: 4799534 · Received May 27, 2015

    Report

    Report Number
    0001825034-2015-02241
    Event Type
    Injury
    Date Received
    May 27, 2015
    Report Date
    October 18, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY STEPHEN M. HOWELL IN INTERNATIONAL ORTHOPAEDICS (SICOT) DOI 10.1007/S00264-015-2743-5. MANUFACTURE DATE ¿ UNKNOWN. IT IS LIKELY THAT THESE COMPLICATIONS AND REVISIONS HAVE ALREADY BEEN REPORTED; HOWEVER, IT CANNOT BE DETERMINED BASED ON THE LIMITED INFORMATION MADE AVAILABLE IN THE ARTICLE. SHOULD ADDITIONAL INFORMATION RELATING TO THE EVENTS BE RECEIVED, THE UPDATED INFORMATION WILL BE FORWARDED TO THE FDA.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THIS REPORT IS TO ADDRESS ONLY ONE EVENT OF THE ARTICLE. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE IS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "DOES VARUS ALIGNMENT ADVERSELY AFFECT IMPLANT SURVIVAL AND FUNCTION SIX YEARS AFTER KINEMATICALLY ALIGNED TOTAL KNEE ARTHROPLASTY?" WHICH AIMED TO TEST THE HYPOTHESIS THAT VARUS ALIGNMENT OF THE TIBIAL COMPONENT, KNEE, OR LIMB DOES NOT ADVERSELY AFFECT IMPLANT SURVIVAL AND FUNCTION. THIS STUDY USED THE VANGUARD, MANUFACTURED AT BIOMET. THIS STUDY CONSISTED OF 214 CONSECUTIVE PATIENTS AND 219 KNEES TREATED WITH A KINEMATICALLY ALIGNED TOTAL KNEE ARTHROPLASTY IN 2007. AS A MEAN OF 6.3 YEARS, THE IMPLANT SURVIVORSHIP WAS 97.5% AND THE REVISION RATE PER 100 COMPONENT YEARS WAS 0.40. THE JOURNAL ARTICLE REPORTS THE FOLLOWING REVISIONS: ONE DUE TO DEEP INFECTION, ONE DUE TO LOOSE TIBIAL COMPONENT AND ONE PATELLA INSTABILITY. ADDITIONALLY, TWO LOOSE PATELLA COMPONENTS WERE PENDING REVISION AND CONSIDERED FAILURES. AT A MEAN OF 6.3 YEARS AFTER KINEMATICALLY ALIGNED TOTAL KNEE ARTHROPLASTY, VARUS ALIGNMENT OF THE TIBIAL COMPONENT, KNEE AND LIMB DID NOT ADVERSELY AFFECT IMPLANT SURVIVAL OR FUNCTION. THIS SUPPORTS THE CONSIDERATION OF KINEMATIC ALIGNMENT AS AN ALTERNATIVE TO MECHANICAL ALIGNMENT FOR PERFORMING PRIMARY TOTAL KNEE ARTHROPLASTY.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "DOES VARUS ALIGNMENT ADVERSELY AFFECT IMPLANT SURVIVAL AND FUNCTION SIX YEARS AFTER KINEMATICALLY ALIGNED TOTAL KNEE ARTHROPLASTY?" WHICH AIMED TO TEST THE HYPOTHESIS THAT VARUS ALIGNMENT OF THE TIBIAL COMPONENT, KNEE, OR LIMB DOES NOT ADVERSELY AFFECT IMPLANT SURVIVAL AND FUNCTION. THIS STUDY USED THE VANGUARD, MANUFACTURED AT BIOMET. THIS STUDY CONSISTED OF 214 CONSECUTIVE PATIENTS AND 219 KNEES TREATED WITH A KINEMATICALLY ALIGNED TOTAL KNEE ARTHROPLASTY IN 2007. AS A MEAN OF 6.3 YEARS, THE IMPLANT SURVIVORSHIP WAS 97.5% AND THE REVISION RATE PER 100 COMPONENT YEARS WAS 0.40. THE JOURNAL ARTICLE REPORTS THE FOLLOWING REVISIONS: ONE DUE TO DEEP INFECTION SIX MONTHS POST-OPERATIVE, NOT LIKELY DUE TO INFECTED IMPLANTS ONE DUE TO LOOSE TIBIAL COMPONENT AND ONE PATELLA INSTABILITY ADDITIONALLY, TWO LOOSE PATELLA COMPONENTS WERE PENDING REVISION AND CONSIDERED FAILURES. PATIENTS WERE REPORTED TO HAVE POSITIVE RESOLUTION AFTER ADVERSE EVENTS OCCURRED. AT A MEAN AGE OF 6.3 YEARS AFTER KINEMATICALLY ALIGNED TOTAL KNEE ARTHROPLASTY, VARUS ALIGNMENT OF THE TIBIAL COMPONENT, KNEE AND LIMB DID NOT ADVERSELY AFFECT IMPLANT SURVIVAL OR FUNCTION. THIS SUPPORTS THE CONSIDERATION OF KINEMATIC ALIGNMENT AS AN ALTERNATIVE TO MECHANICAL ALIGNMENT FOR PERFORMING PRIMARY TOTAL KNEE ARTHROPLASTY.

    Description of Event or Problem · 1

    REVIEW OF THE JOURNAL ARTICLE AND MEDICAL RECORDS IDENTIFIED A PATIENT THAT UNDERWENT INFECTION<1 YEAR POST IMPLANT ON AN UNKNOWN DATE. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENT OUTCOME IS UNKNOWN. ALL OTHER EVENTS WILL BE REPORTED IN INDIVIDUAL RECORDS WHICH WILL BE LINKED TO THIS PARENT RECORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343747 UNKNOWN KNEE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R