BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AGC KNEE

    MDR report key: 4197840 · Received October 23, 2014

    Report

    Report Number
    0001825034-2014-08200
    Event Type
    Injury
    Date Received
    October 23, 2014
    Report Date
    November 2, 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
    IN, 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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN. BRAND NAME - UNKNOWN. CATALOG NUMBER, LOT NUMBER AND EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. DATE EXPLANTED - UNKNOWN. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY PHILIP M. FARIS MD, E. MICHAEL KEATING MD, ALEX FARRIS, JOHN B. MEDING MD, MERRILL A. RITTER MD; CLIN ORTHOP RELAT RES (2008) 466:1204¿1209 DOI 10.1007/S11999-008-0195-6. 510K NUMBER - UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO ADDRESS ONLY ONE EVENT OF THE ARTICLE. THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL/ UPDATED INFORMATION. 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 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. 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

    ONE PATIENT WAS IDENTIFIED IN THE ARTICLE THAT UNDERWENT KNEE INCIDENCE OF OSTEOLYSIS 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.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "HYBRID TOTAL KNEE ARTHROPLASTY: 13-YEAR SURVIVORSHIP OF AGC TOTAL KNEE SYSTEMS WITH AVERAGE 7 YEARS FOLLOW-UP¿ WHICH DISCUSSED A RETROSPECTIVE STUDY PERFORMED IN RESPONSE TO CONFLICTING DATA IN THE LITERATURE CONCERNING THE BENEFITS OF A HYBRID FIXATION METHOD FOR TKA. THE STUDY FOLLOWED ONE-HUNDRED THIRTY-ONE (131 PATIENTS) WHO RECEIVED TWO-HUNDRED AND ONE (201) HYBRID KNEES BETWEEN AUGUST 24, 1988 AND MAY 17, 1989. SELECTION FOR HYBRID FIXATION WAS NONRANDOMIZED AND BASED ON FEMORAL COMPONENT FIT. SURVIVORSHIP ANALYSIS WAS PERFORMED, AND RATES OF RADIOLUCENT LINES SURROUNDING THE FEMORAL COMPONENT AND OCCURRENCE OF OSTEOLYSIS WERE NOTED. THE JOURNAL ARTICLE REPORTS THE FOLLOWING ADVERSE EVENTS: FIVE (5) REVISIONS OF THE FEMORAL OR TIBIAL COMPONENT; TWO (2) OF WHICH WERE NOT RELATED TO INFECTION. TWO (2) ASEPTIC REVISIONS RESULTED FROM MEDIAL TIBIAL COLLAPSE SECONDARY TO LOOSENING. ONE (1) INCIDENCE OF OSTEOLYSIS. SEVEN (7) MANIPULATIONS. THREE (3) LATERAL RELEASE PROCEDURES. ONE (1) REVISION OF THE PATELLA BUTTON. THE ARTICLE CONCLUDED THAT THE HYBRID FIXATION IN A SELECTED PATIENT POPULATION CAN RESULT IN EXCELLENT RESULTS IN MIDDLE TO LONG-TERM FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675285 UNKNOWN AGC KNEE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R