BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZLOC/WASHERLOC DISPOSABLE KIT

    MDR report key: 6341351 · Received February 17, 2017

    Report

    Report Number
    0001825034-2017-00591
    Event Type
    Injury
    Date Received
    February 17, 2017
    Date of Event
    February 21, 2017
    Report Date
    September 11, 2017
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    Z-1827-2016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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. CONCOMITANT PRODUCTS: COMPOSITCP 60 10X35MM INT. SCREW CATALOG#:905262 LOT#:143957. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-00590/ 0001825034-2017-02519/ 0001825034-2017-02522/ 0001825034-2017-02524/ 0001825034-2017-02525.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED THROUGH RECEIPT OF MEDICAL RECORDS AND OPERATIVE NOTES. MEDICAL RECORDS WERE REVIEWED WHICH COVER THE REMOVAL OF THE PREVIOUSLY IMPLANTED ACL GRAFT, "DEEP HARDWARE, PROXIMAL TIBIA" AND "DEEP HARDWARE, RIGHT LATERAL DISTAL FEMUR." IT IS CALLED OUT IN THE REPORT THAT A MAJOR SYNOVECTOMY WAS REQUIRED TO REMOVE "A SIGNIFICANT AMOUNT OF HYPERTROPHIC TISSUE NOTED ANTERIORLY." DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. THIS PRODUCT IS IN SCOPE OF PREVIOUS CORRECTIVE ACTION, HOWEVER, ROOT CAUSE WAS UNABLE TO BE CONFIRMED FOR THIS EVENT. 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.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT IS NUMBER 2 OF 2 FILED FOR THE SAME PATIENT. (REFERENCE 0001825034 - 2017 -00590 / 00591). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT-BIOMET 9-10MM STANDARD EZLOC FEM FIXA, CATALOG#: 904781, LOT#: 607100.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION REVISION PROCEDURE APPROXIMATELY TWENTY (20) MONTHS POST-IMPLANTATION DUE TO PAIN, STIFFNESS, AND SUSPECTED INFECTION. THE SURGEON WAS REPORTEDLY ATTEMPTING TO TREAT THE PATIENT FOR INFECTION FOR APPROXIMATELY A YEAR, PRIOR TO REMOVAL. REVISION OPERATIVE NOTES RECEIVED NOTED HYPERTROPHIC TISSUE AND THICKENED TISSUE. A SYNOVECTOMY, DEBRIDEMENT, AND GRAFT AND HARDWARE REMOVAL WERE PERFORMED. THE PATIENT WAS THEN PRESCRIBED ANTIBIOTICS.

    Description of Event or Problem · 1

    PATIENT UNDERWENT AN ACL RECONSTRUCTION PROCEDURE, AND HAS SUBSEQUENTLY DEVELOPED AN INFECTION. THE SURGEON HAS BEEN ATTEMPTING TO TREAT THE INFECTION FOR APPROXIMATELY ONE YEAR, BUT A FUTURE REVISION SURGERY MAY BE INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123409 EZLOC/WASHERLOC DISPOSABLE KIT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET SPORTS MEDICINE NI 529190

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| O| R