BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN, KNEE

    MDR report key: 4782175 · Received May 19, 2015

    Report

    Report Number
    0001825034-2015-02039
    Event Type
    Death
    Date Received
    May 19, 2015
    Report Date
    December 14, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    NRA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    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. (B)(6). 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

    ZIMMER BIOMET COMPLAINT: (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER AND LOT NUMBER OF THE DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD 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. 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. MIETTINEN, S.S.A. ¿MID-TERM RESULTS OF OXFORD PHASE 3 UNICOMPARTMENTAL KNEE ARTHROPLASTIES AT A SMALL-VOLUME CENTER.¿ SCANDINAVIAN JOURNAL OF SURGERY, 2015, PP. 1¿8. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "MID-TERM RESULTS OF OXFORD PHASE 3 UNICOMPARTMENTAL KNEE ARTHROPLASTIES (UKA) AT A SMALL-VOLUME CENTER" WHICH AIMED TO FIND OUT CLINICAL AND RADIOLOGICAL OUTCOMES AND RELATED COMPLICATIONS USING THE OXFORD PHASE 3 PROSTHESIS AT A SMALL-VOLUME CENTER. THE STUDY WAS CONDUCTED OVER A 10 YEAR PERIOD (2000-2010) AND INVOLVED SURGERY ON 87 PATIENTS AND 95 OXFORD KNEES. IN ALL, 52 KNEE ARTHROPLASTIES PARTICIPATED IN THE STUDY. WITHIN THE ARTICLE, THERE WERE FIVE NOTED REVISIONS: TWO AS A RESULT OF PROGRESSION OF KNEE OSTEOARTHRITIS, ONE AS A RESULT OF COMPONENT MALALIGNMENT, ONE AS A RESULT OF IMPLANT LOOSENING, ONE AS A RESULT OF DISLOCATION. THERE WERE ALSO TWELVE OTHER MINOR PROBLEMS NOTED THAT DID NOT RESULT IN A REVISION PROCEDURE: ONE DUE TO SUPERFICIAL INFECTION, NINE DUE TO PAIN, ONE PULMONARY EMBOLISM, AND ONE LOOSE BONY BODIES THAT WERE REMOVED BY ARTHROSCOPY. ADDITIONALLY, SEVEN PATIENTS HAVE DIED DUE TO UNKNOWN REASONS DURING THE FOLLOW UP. THE AUTHORS OF THIS STUDY CONCLUDE THAT UKA SURGERIES SHOULD BE FOCUSED TO WELL-TRAINED ORTHOPEDIC SURGEONS TO ACHIEVE BETTER RESULTS.

    Description of Event or Problem · 1

    SEVEN (7) UNKNOWN DEATHS DURING THE FOLLOW UP TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326998 UNKNOWN, KNEE PROSTHESIS, KNEE NRA ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R