BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN OXFORD KNEE

    MDR report key: 4799490 · Received May 27, 2015

    Report

    Report Number
    0001825034-2015-02237
    Event Type
    Death
    Date Received
    May 27, 2015
    Report Date
    November 8, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO ADDRESS ONLY ONE EVENT OF THE ARTICLE. THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL/ UPDATED INFORMATION. OUTCOMES ATTRIBUTED TO ADVERSE EVENT. EVENT OR PROBLEM. BRAND NAME. CATALOG AND LOT NUMBER. PATIENT AND DEVICE CODES. REPORT SOURCE. TYPE OF REPORTABLE EVENT. DEVICE EVALUATED BY MANUFACTURER. METHOD, RESULTS, AND CONCLUSION CODES. MANUFACTURER NARRATIVE. 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. 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. ZIMMER BIOMET COMPLAINT: (B)(4). THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. PRODUCT LOCATION UNKNOWN.

    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 ADAM G. BERGESON ET AL IN THE JOURNAL OF ANTROPLASTY (2013).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE ENTITLED, "MEDIAL MOBILE BEARING UNICOMPARTMENTAL KNEE ARTHROPLASTY EARLY SURVIVORSHIP AND ANALYSIS OF FAILURES IN 1000 CONSECUTIVE CASES." THE PURPOSE OF THIS STUDY IS TO REPORT THE EARLY SURVIVORSHIP AND FAILURE MODES IN A SERIES OF 1000 CONSECUTIVE MEDIAL MOBILE BEARING UKA. UKA PATIENTS WITH A MINIMUM OF 2 YEAR FOLLOW-UP OR THOSE MEETING THE STUDY ENDPOINT (UKA FAILURE OR DEATH) WERE INCLUDED. DEMOGRAPHIC VARIABLES, PRE AND POST-OPERATIVE CLINICAL VARIABLES, AND MODE OF FAILURE WERE ANALYZED. EIGHT HUNDRED AND THIRTY-NINE KNEES WERE INCLUDED IN THE ANALYSIS. FORTY REVISIONS WERE PERFORMED AT AN AVERAGE OF 23.1 MONTHS (RANGE, 2.3-74.2) FOLLOWING UKA FOR A SURVIVORSHIP OF 95.2%. INDICATIONS FOR REVISION WERE ASEPTIC LOOSENING (15 ), TIBIAL COLLAPSE (7), MOBILE BEARING DISLOCATION (2), PERSISTENT PAIN (12), PROGRESSION OF DISEASE (2), INFECTION (1), AND TIBIOFEMORAL INSTABILITY (1). FROM JULY 2004 TO DECEMBER 2008, 3563 PATIENTS (4556 KNEES) WITH END-STAGE DEGENERATIVE JOINT DISEASE OF AT LEAST ONE KNEE COMPARTMENT UNDERWENT KNEE ARTHROPLASTY BY ONE OF THE SENIOR AUTHORS (AVL. KRB ). PRIMARY TOTAL KNEE ARTHROPLASTY WAS PERFORMED IN 3481 KNEES (76%), PATELLOFEMORAL ARTHROPLASTY IN 7 ( <1%), LATERAL FIXED-BEARING UKA IN 64 (1%), MEDIAL UKA WITH COMBINED ARTHROSCOPIC RECONSTRUCTION OF THE ANTERIOR CRUDATE LIGAMENT (ACL) IN 4 (<1%), AND MEDIAL MOBILE-BEARING UKA IN 1000 KNEES (22%) IN 808 PATIENTS. AT A MINIMUM OF 24 MONTHS FOLLOW-UP AND AT AN AVERAGE 44.4 MONTHS FOLLOW-UP, 40 KNEES (4.8%) HAD BEEN REVISED FOR A SURVIVORSHIP OF 95.2%. REVISIONS OCCURRED AT AN AVERAGE OF 23.1 MONTHS (RANGE, 2.3-74.2 MONTHS). SIXTEEN NON-REVISION REOPERATIONS PERFORMED ON 16 KNEES IN 16 DIFFERENT PATIENTS WERE RECORDED AT THE TIME OF MOST RECENT FOLLOW UP. THIRTY-ONE (31) PATIENTS HAD DIED (THIRTY-FOUR (34) KNEES) SINCE UNDERGOING UKA. CAUSE OF DEATH FOR EACH PATIENT IS UNKNOWN. IN CONCLUSION, THERE WAS A REPORTED 95.2% SURVIVORSHIP AT AN AVERAGE OF 44.4 MONTHS IN 839 MEDIAL MOBILE BEARING OXFORD UKAS. A PREDOMINANCE OF EARLY FAILURE DUE TO ASEPTIC TIBIAL LOOSENING AND COLLAPSE AS WELL AS TO PERSISTENT PAIN WAS DEMONSTRATED. INCREASED MEDIAL TIBIAL STRAIN FOLLOWING UKA LIKELY UNDERLIES THIS OBSERVATION. THE STUDY DEMONSTRATES THAT MEDIAL MOBILE BEARING UKA IS A GOOD OPTION FOR TREATMENT OF ANTEROMEDIAL OA WITH EXCELLENT SURVIVORSHIP AND IMPROVEMENT IN FUNCTIONAL OUTCOMES SCORES AND KNEE RANGE OF MOTION AT THIS EARLY FOLLOW UP INTERVAL.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE ENTITLED, "MEDIAL MOBILE BEARING UNICOMPARTMENTAL KNEE ARTHROPLASTY EARLY SURVIVORSHIP AND ANALYSIS OF FAILURES IN 1000 CONSECUTIVE CASES." THERE ARE MULTIPLE EVENTS REPORTED IN THE ARTICLE. THIS REPORT ADDRESSES THE 31 PATIENTS (34 KNEES) THAT WERE IDENTIFIED IN THE ARTICLE THAT DIED OF UNKNOWN REASONS SINCE UNDERGOING UKA. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344117 UNKNOWN OXFORD KNEE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R