BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI TIB TRAY SZ E RM PMA

    MDR report key: 11107948 · Received January 4, 2021

    Report

    Report Number
    3002806535-2021-00001
    Event Type
    Injury
    Date Received
    January 4, 2021
    Date of Event
    December 16, 2020
    Report Date
    January 20, 2021
    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
    KY, US
    Reporter Occupation
    PHYSICIAN

    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, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00002-1. 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 X-RAYS OR ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND NO SIMILAR COMPLAINTS REPORTED WITH THE ITEM AND LOT COMBINATION. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND NO SIMILAR COMPLAINTS REPORTED WITH THE ITEM 154727 AND 3 SIMILAR COMPLAINTS REPORTED WITH THE ITEM 161470. TRENDS WERE IDENTIFIED WITH RESPECT TO SIMILAR COMPLAINTS. 2 COMPLAINTS OF ITEM 161470 ARE FOUND TO HAVE SAME SURGEON NAME. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. RISK ASSESSMENT: THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED WITH THE INFORMATION CURRENTLY AVAILABLE, THEREFORE THE SPECIFIC FAILURE CAUSE WITHIN THE RISK TABLE COULD NOT BE SELECTED FOR COMPARISON. FOR ITEM 154727, LOT 2984957: RISK MANAGEMENT REPORT DOCUMENTS THE ESTIMATED RESIDUAL RISK ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED EVENT STATES REVISION DUE TO LOOSENING. LOSS OF FIXATION IS DOCUMENTED AS A POTENTIAL HARM AS AN OUTCOME OF A NUMBER OF HAZARDS ASSESSED BY THE ABOVE REFERENCED RMF. LOSS OF FIXATION IS CONSIDERED A SEVERITY OF 3: MODERATE, WHICH AS PER THE SEVERITY TABLE LISTED WITHIN THE RMR IS DEFINED AS PRESCRIBED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR BODY STRUCTURE. CONTRIBUTED TO MINOR, TEMPORARY, OR MEDICALLY REVERSIBLE INJURY. THE OUTCOME OF THE REPORTED EVENT (SURGICAL INTERVENTION) IS CONSIDERED TO BE WITHIN THE SEVERITY OF THE RMR. FOR ITEM 161470, LOT 954240: RISK MANAGEMENT REPORT DOCUMENTS THE ESTIMATED RESIDUAL RISK ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED EVENT STATES REVISION DUE TO LOOSENING. LOSS OF FIXATION IS DOCUMENTED AS A POTENTIAL HARM AS AN OUTCOME OF A NUMBER OF HAZARDS ASSESSED BY THE ABOVE REFERENCED RMF. LOSS OF FIXATION IS CONSIDERED A SEVERITY OF 3: MODERATE, WHICH AS PER THE SEVERITY TABLE LISTED WITHIN THE RMR IS DEFINED AS PRESCRIBED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR BODY STRUCTURE. CONTRIBUTED TO MINOR, TEMPORARY, OR MEDICALLY REVERSIBLE INJURY. THE OUTCOME OF THE REPORTED EVENT (SURGICAL INTERVENTION) IS CONSIDERED TO BE WITHIN THE SEVERITY OF THE RMR. OCCURENCE: IN ORDER TO CALCULATE THE OCCURRENCE RATE, SALES AND COMPLAINT DATA FOR THESE ITEM NUMBERS HAS BEEN OBTAINED, AND IS ATTACHED FOR A PERIOD OF THE LAST 3 CALENDAR YEARS PRIOR TO NOTIFICATION DATE, BEING DECEMBER 2020. FOR ITEM 154727, LOT 2984957: SALES (DEC 2017 TO DEC 2020) = (B)(4). COMPLAINTS SEARCH WAS CONDUCTED FOR EVENTS OCCURRING BETWEEN DEC 2017 TO DEC 2020 FOR ITEM 154727. 4 COMPLAINTS WERE IDENTIFIED FOR THIS ITEM NUMBER INCLUDING (B)(4). THEREFORE, THE CALCULATED OCCURRENCE RATE IS 4 IN (B)(4). MULTIPLE HAZARDS AND HAZARDOUS SITUATIONS RESULT IN A HARM OF LOSS OF FIXATION. THE ROOT CAUSE OF THE ABOVE COMPLAINT HAS NOT BEEN DETERMINED, THEREFORE A SPECIFIC HAZARD CANNOT BE SELECTED. AS A HAZARD CANNOT BE SELECTED, THE OCCURRENCE SCORE FOR ONE HAZARD CANNOT BE ATTRIBUTED TO ALL EVENTS, AND THEREFORE CANNOT BE USED FOR COMPARISON. FOR ITEM 161470, LOT 954240: SALES (DEC 2017 TO DEC 2020) = (B)(4). COMPLAINTS SEARCH WAS CONDUCTED FOR EVENTS OCCURRING BETWEEN DEC 2017 TO DEC 2020 FOR ITEM 161470. 18 COMPLAINTS WERE IDENTIFIED FOR THIS ITEM NUMBER INCLUDING (B)(4). THEREFORE, THE CALCULATED OCCURRENCE RATE IS 18 IN (B)(4). MULTIPLE HAZARDS AND HAZARDOUS SITUATIONS RESULT IN A HARM OF LOSS OF FIXATION. THE ROOT CAUSE OF THE ABOVE COMPLAINT HAS NOT BEEN DETERMINED, THEREFORE A SPECIFIC HAZARD CANNOT BE SELECTED. AS A HAZARD CANNOT BE SELECTED, THE OCCURRENCE SCORE FOR ONE HAZARD CANNOT BE ATTRIBUTED TO ALL EVENTS, AND THEREFORE CANNOT BE USED FOR COMPARISON. 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 A PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO LOOSE FEMORAL/TIBIAL COMPONENT WAS PERFORMED ON (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. CUSTOMER HAS INDICATED THAT THE PRODUCTS WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THEY HAVE BEEN DISCARDED. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: OXF TWIN-PEG CMNTD FEM LG PMA, CATALOG #: 161470, LOT #: 954240. MEDICAL PRODUCT: OXF ANAT BRG RT LG SIZE 4 PMA, CATALOG #: 159583, LOT #: 3029871. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00002, 3002806535-2021-00003. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. THE PRODUCT HAS BEEN DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO LOOSE FEMORAL/TIBIAL COMPONENT WAS PERFORMED ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9944 OXF UNI TIB TRAY SZ E RM PMA KNEE ARTHROPLASTY NRA BIOMET UK LTD. N/A 2984957

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R