BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE

    MDR report key: 5477213 · Received March 3, 2016

    Report

    Report Number
    0001825034-2016-00739
    Event Type
    Injury
    Date Received
    March 3, 2016
    Report Date
    October 26, 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
    DA
    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 PATIENT MENTIONED IN THE JOURNAL ARTICLE. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN. DEVICE CODE - UNKNOWN. EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. DATE EXPLANTED - UNKNOWN. (B)(6). MANUFACTURE DATE ¿ UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION DUE TO UNKNOWN LOCATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD (DHR) AND COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT/ITEM 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION, UNDER POSSIBLE ADVERSE EVENTS: EARLY OR LATE POSTOPERATIVE INFECTION AND/OR ALLERGIC REACTION. 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, "MORBIDITY AND MORTALITY AFTER BILATERAL SIMULTANEOUS TOTAL KNEE ARTHROPLASTY IN A FAST-TRACK SETTING" WHICH WAS A RETROSPECTIVE SINGLE-CENTER STUDY INVESTIGATING EARLY MORBIDITY AND MORTALITY FOLLOWING BILATERAL SIMULTANEOUS TOTAL KNEE ARTHROPLASTY (BSTKA) IN A MODERN FAST-TRACK SETTING, AND THE STUDY IDENTIFIED RISK FACTORS FOR RE-ADMISSION WITHIN 90 DAYS AND FOR A LENGTH OF STAY (LOS) OF MORE THAN 5 DAYS, USING THE AGC KNEE AND VANGUARD KNEE, MANUFACTURED AT BIOMET. THIS STUDY CONSISTED OF 284 PATIENTS WHO RECEIVED BSTKA FROM 2008 THROUGH 2014. 90 DAY MORTALITY WAS 0%, 10% OF PATIENTS WERE READMITTED WITHIN 90 DAYS. 153 PATIENTS RECEIVED POSTOPERATIVE BLOOD TRANSFUSIONS. SURGICAL SITE INFECTION TREATED EITHER WITH ANTIBIOTICS ALONE OR WITH REVISION WAS THE MOST COMMON REASON FOR READMISSION. IN CONCLUSION, BSTKA IN SELECTED PATIENTS WITHOUT CARDIOPULMONARY DISEASE IN A FAST-TRACK SETTING APPEARS TO BE SAFE REGARDING EARLY POSTOPERATIVE MORBIDITY AND MORTALITY.

    Description of Event or Problem · 1

    A REVIEW OF THE ARTICLE IDENTIFIED TWO (2) UNKNOWN PATIENTS THAT WERE RE-ADMITTED WITHIN 90 DAYS DUE TO SUPERFICIAL SURGICAL SITE INFECTION WHICH WAS TREATED WITH ANTIBIOTICS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED AND THE PATIENTS OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134696 UNKNOWN KNEE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R