BEUDAMED
    FDA Adverse Event Death Summary report: N

    OXF TWIN-PEG CMNTD FEM SM PMA

    MDR report key: 10178345 · Received June 22, 2020

    Report

    Report Number
    3002806535-2020-00293
    Event Type
    Death
    Date Received
    June 22, 2020
    Date of Event
    July 6, 2019
    Report Date
    September 10, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279438228
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT: 3002806535-2020-00291-1, 3002806535-2020-00292-1. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED. RADIOGRAPHS: FOURTEEN RADIOGRAPHS WERE PROVIDED FOR ANALYSIS WITH (B)(4), ONE ANTEROPOSTERIOR (AP) AND ONE MEDIOLATERAL (ML) FOR EACH FOLLOW-UP VISIT AT 6 WEEKS, 6 MONTHS, 1 YEAR, 2 YEARS, 3 YEARS, 4 YEARS AND 5 YEARS. ONLY RADIOGRAPHS SHOWING THE RIGHT KNEE (ASSOCIATED WITH COMPLAINT (B)(4)) HAVE BEEN ASSESSED. ALL PROVIDED RADIOGRAPHS OF THE RIGHT KNEE SHOW ADEQUATELY SIZED AND POSITIONED COMPONENTS OF THE OXFORD PARTIAL KNEE SYSTEM. AT THE PRE-OPERATIVE VISIT ((B)(6) 2014), THE PATIENT PRESENTED WEIGHT OF 72.6 KG AND A HEIGHT OF 1.63 M, THUS HAVING A BMI OF 27.33 (OVERWEIGHT). THE KSS AND OXFORD ASSESSMENT SCORES WERE EXCELLENT AT POST-OPERATIVE VISITS, EXCEPT FROM A SLIGHTLY LOWER OXFORD KNEE SCORE OF 36 AT THE 3-YEAR POSTOPERATIVE VISIT ((B)(6) 2017). IT IS TO BE NOTED THAT THE PATIENT REPORTED AN ADVERSE EVENT, DESCRIBED AS PATIENT FELL ON RIGHT KNEE ABOUT A MONTH AGO, SHE HAS MILD POSTERIOR KNEE PAIN AND WEAKNESS AFTER THE FALL, ABOUT A MONTH BEFORE THIS VISIT (DATE OF ONSET (B)(6) 2017). THEREFORE, THIS ADVERSE EVENT MAY HAVE CONTRIBUTED TO THE OBSERVED LOWER OXFORD KNEE SCORE. MOREOVER, THIS ADVERSE EVENT WAS MARKED AS NOT RELATED TO THE DEVICE BY THE PHYSICIAN, AND THE EVENT WAS RECORDED AS TOLERATED WITH NO TREATMENT. BASED ON THE RADIOGRAPHS PROVIDED WITH (B)(4) AND ON THE INFORMATION REPORTED IN THE CASE REPORT FORM (CRF), IT IS CONCLUDED THAT THE REPORTED PATIENT DEATH IS UNRELATED TO THE OXFORD KNEE SYSTEM ASSOCIATED WITH THE COMPLAINT. THE MANUFACTURING HISTORY RECORDS (MHRS) FOR THE OXFORD ANATOMIC BEARING, TIBIAL TRAY AND FEMORAL COMPONENT HAVE BEEN CHECKED AND VERIFY THAT THE PARTS WERE MANUFACTURED AND STERILISED IN ACCORDANCE WITH THE APPLICABLE SPECIFICATIONS, AND NO ABNORMALITIES OR DEVIATIONS REPORTED. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. RISK ASSESSMENT: THE DETAILS OF THE REPORTED EVENT CONCLUDE THAT THE REPORTED DEATH OF THE PATIENT IS UNRELATED TO THE DEVICE. THEREFORE, RISK ASSESSMENT CANNOT BE CONDUCTED WITH THE INFORMATION PROVIDED. NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY. H3 OTHER TEXT : PRODUCT HAS NOT BEEN RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CLINICAL STUDY GROUP THAT THEY RECEIVED NOTIFICATION THAT PATIENT WHO WAS ENROLLED IN THE (B)(6) HAD DIED ON (B)(6) 2019 DUE TO UNKNOWN REASONS. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2014 AND RECEIVED THE CONTROL DEVICE (CEMENTED OXFORD). THE DEATH WAS NOT DEVICE RELATED.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. MEDICAL PRODUCT: OXF UNI TIB TRAY SZ C RM PMA, CATALOG #: 154723, LOT #: 2423675. MEDICAL PRODUCT: OXF ANAT BRG RT SM SIZE 3 PMA, CATALOG #: 159568, LOT #: 129880. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00291, 3002806535-2020-00292. REPORTER OCCUPATION: CLINICAL KNEE ADMIN. 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 CLINICAL STUDY GROUP THAT THEY RECEIVED NOTIFICATION THAT PATIENT WHO WAS ENROLLED IN THE OXFORD IDE HAD DIED ON (B)(6) 2019 DUE TO UNKNOWN REASONS. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2014 AND RECEIVED THE CONTROL DEVICE (CEMENTED OXFORD). THE DEATH WAS NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642821 OXF TWIN-PEG CMNTD FEM SM PMA KNEE ARTHROPLASTY NRA BIOMET UK LTD. N/A 2234831 05019279438228

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death