BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD CEMENTLESS TIBIA E RM

    MDR report key: 8748151 · Received July 1, 2019

    Report

    Report Number
    3002806535-2019-00526
    Event Type
    Injury
    Date Received
    July 1, 2019
    Date of Event
    November 14, 2014
    Report Date
    October 16, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G4, G7, H1, H2, H3, H6, H10. ON THE RADIOGRAPHS TAKEN AT THE 2-YEAR FOLLOW-UP VISIT AND FOLLOWING VISITS, MEDIAL FEMORAL OSTEOPHYTES CAN BE SEEN ON THE ANTERO-POSTERIOR RADIOGRAPHS AND ANTERIOR FEMORAL OSTEOPHYTES CAN BE SEEN ON THE MEDIO-LATERAL RADIOGRAPHS. KSS SCORES AND OXFORD KNEE SCORES RECORDED IN THE CRF REPORT SHOW IMPROVEMENT FROM THE 6-MONTH TO THE 4-YEAR ASSESSMENT. AT THE 4 YEAR FOLLOWUP, THE PATIENT HAD A KSS ASSESSMENT SCORE OF 98 AND A KSS FUNCTIONAL SCORE OF 100, WHICH CAN BE CONSIDERED EXCELLENT AND WOULD INDICATE THAT THE RECURRENT JOINT EFFUSIONS PRIOR TO THIS POINT WERE NOT RELATED TO THE FUNCTION OF THE DEVICE. THE ADVERSE EVENT REPORTS FOR EACH OF THESE EVENTS ALSO SPECIFICALLY STATE THAT THEY WERE NOT RELATED TO THE DEVICE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE HOSPITAL THAT A PATIENT UNDERWENT RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT SUFFERED A LARGE EFFUSION WHICH WAS TREATED WITH ASPIRATION. IT WAS ALSO REPORTED THAT THE SAME PATIENT SUFFERED A FURTHER THREE OCCURRENCES OF EFFUSION.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535 -2019 -00525, 3002806535-2019-00524. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: OXF TWIN-PEG CMNTD FMRL MD, CATALOG #: 161474, LOT #: 2409868. MEDICAL PRODUCT: OXF ANAT BRG RT MD SIZE 3 PMA, CATALOG #: 159575, LOT #: 948670. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HOSPITAL THAT A PATIENT HAD RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT SUFFERED A LARGE EFFUSION WHICH WAS TREATED WITH ASPIRATION. IT WAS ALSO REPORTED THAT THE SAME PATIENT SUFFERED A FURTHER THREE OCCURRENCES OF EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542152 OXFORD CEMENTLESS TIBIA E RM KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 3050489

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R SEE H10