BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    OXF KNEE PH3 I/M ROD RMVL HK

    MDR report key: 11371387 · Received February 24, 2021

    Report

    Report Number
    3002806535-2021-00049
    Event Type
    Malfunction
    Date Received
    February 24, 2021
    Date of Event
    February 6, 2021
    Report Date
    March 19, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HXC
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. WE HAVE NOT BEEN PROVIDED WITH ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF MANUFACTURING HISTORY RECORDS COULD NOT BE PERFORMED AS LOT NUMBER IS NOT AVAILABLE. A REVIEW OF COMPLAINT HISTORY SEARCH HAS CONFIRMED 7 SIMILAR COMPLAINTS FOR THIS ITEM NUMBER INCLUDING (B)(4). WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. RISK ASSESSMENT: RISK MANAGEMENT REPORT DOCUMENTS THE ESTIMATED RESIDUAL RISK ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED EVENT STATES INSTRUMENT BROKEN. THIS HAZARD INCLUDES A HARM OF EXPOSURE TO ANESTHESIA, MINOR WHICH HAS A SEVERITY OF 2 (MINOR) DEFINED WITHIN THE SEVERITY TABLE AS: ILLNESS OR INJURY THAT DOES NOT REQUIRE PRESCRIBED MEDICAL OR SURGICAL INTERVENTIONS. IN ORDER TO CALCULATE THE OCCURRENCE RATE, SALES AND COMPLAINT DATA FOR THIS ITEM NUMBER HAVE BEEN OBTAINED FOR A PERIOD OF THE LAST 3 YEARS PRIOR TO THE NOTIFICATION DATE, BEING MARCH 2021. SALES (FEB 2018 TO FEB 2021): (B)(4) UNITS. COMPLAINTS SEARCH WAS CONDUCTED FOR EVENTS OCCURRING BETWEEN FEB 2018 TO FEB 2021 FOR ITEM: 32-401111. 7 SIMILAR COMPLAINTS WERE IDENTIFIED FOR THIS ITEM NUMBER INCLUDING (B)(4). (B)(4). OCCURRENCE CALCULATION: 2: REMOTE (1:100,000 TO 1:10,000). RMF ESTIMATES: 2: REMOTE (1:100,000 TO 1:10,000). THE OUTCOME OF THIS COMPLAINT IS CONSIDERED TO BE WITHIN THE SEVERITY OF THE RMF. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INITIAL OXFORD UNI KNEE ARTHROPLASTY, IT WAS DISCOVERED THAT THE HOOK WAS BROKEN ON IM FEMORAL ROD. THE DECISION WAS MADE TO GET ANOTHER OXFORD SET FROM ANOTHER HOSPITAL. THERE WAS A DELAY IN SURGERY OF 20 MINUTES. THERE WAS NO HARM TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(4). PRODUCT HAS BEEN REQUESTED TO BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. POSTAL CODE: (B)(6). 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 THAT DURING AN INITIAL OXFORD UNI KNEE ARTHROPLASTY, IT WAS DISCOVERED THAT THE HOOK WAS BROKEN ON IM FEMORAL ROD. THE DECISION WAS MADE TO GET ANOTHER OXFORD SET FROM ANOTHER HOSPITAL. THERE WAS A DELAY IN SURGERY OF 20 MINUTES. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270022 OXF KNEE PH3 I/M ROD RMVL HK BMET GENERAL KNEE INSTRUMENTS HXC BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1