BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG LT MD SIZE 6 PMA

    MDR report key: 9915699 · Received April 2, 2020

    Report

    Report Number
    3002806535-2020-00202
    Event Type
    Injury
    Date Received
    April 2, 2020
    Report Date
    May 21, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279785964
    PMA / PMN Number
    PO1004
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D11: MEDICAL PRODUCT: OXF UNI TIB TRAY SZ C LM PMA, CATALOG #: 154722, LOT #: 2478416. MEDICAL PRODUCT: OXF TWIN-PEG CMNTD FEM MD PMA, CATALOG #: 161469, LOT #: 2465467. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00203-1, 3002806535-2020-00204-1. 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 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 159550, (B)(4) SIMILAR COMPLAINTS REPORTED WITH THE ITEM 154722 AND (B)(4) SIMILAR COMPLAINTS REPORTED WITH THE ITEM 161469. TRENDS WERE IDENTIFIED FROM COMPLAINT HISTORY REVIEW. FOR ITEM 161469, (B)(4) COMPLAINTS WERE REPORTED IN SAME HOSPITAL. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. RISK ASSESSMENT: THE EVENT REPORTS PAIN AND SWELLING. RISK MANAGEMENT REPORT DOCUMENTS THE ESTIMATED RESIDUAL RISK ASSOCIATED WITH THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED WITH THE INFORMATION CURRENTLY AVAILABLE. CLINICAL REPORT FORM ((B)(6)) STATES THE REPORTED EVENT IS NOT DEVICE RELATED, AND DOCUMENTS THE DETAILS OF TREATMENT AS EXERCISES AND THE OUTCOME AS TOLERATED. HOWEVER, IN THE RISK FILE, PAIN IS CONSIDERED HARM WITH A SEVERITY LEVEL OF 3 FOR A NUMBER OF HAZARDS DEFINED AS MODERATE, WHICH IS DESCRIBED IN THE SEVERITY TABLE AS: S-3 PRESCRIBED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR BODY STRUCTURE. CONTRIBUTED TO MINOR, TEMPORARY, OR MEDICALLY REVERSIBLE INJURY. SWELLING IS ALSO CONSIDERED A HARM FOR MULTIPLE LINES IN THE RISK FILE WITH A SEVERITY SCORE NOT EXCEEDING 3. THEREFORE, THE REPORTED EVENT IS CONSIDERED TO BE WITHIN THE SEVERITY OF THE RMR. CORRECTIVE ACTION TAKEN: NO CORRECTIVE ACTION REQUIRED AT THIS TIME. PREVENTIVE ACTION TAKEN: NO PREVENTIVE ACTION REQUIRED 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 AS PART OF CLINICAL STUDY (B)(6) THAT THE PATIENT WAS SUFFERING FROM PAIN AND SWELLING IN LEFT KNEE. THE PAIN AND SWELLING WAS TREATED WITH EXERCISES. THE OUTCOME IS RECORDED AS TOLERATED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. CUSTOMER HAS INDICATED THAT THE PRODUCT REMAINS IMPLANTED IN THE PATIENT. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: OXF UNI TIB TRAY SZ C LM PMA, CATALOG # 154722, LOT # 2478416. MEDICAL PRODUCT: OXF TWIN-PEG CMNTD FEM MD PMA , CATALOG # 161469, LOT # 2465467. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00203, 3002806535-2020-00204. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICES REMAIN IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED AS PART OF CLINICAL STUDY (B)(6) THAT THE PATIENT WAS SUFFERING FROM PAIN AND SWELLING IN LEFT KNEE. THE PAIN AND SWELLING WAS TREATED WITH EXERCISES. THE OUTCOME IS RECORDED AS TOLERATED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378700 OXF ANAT BRG LT MD SIZE 6 PMA KNEE PROTHESIS NRA BIOMET UK LTD. N/A 2475812 05019279785964

    Patients

    Seq Age Sex Outcome Treatment
    1 Other