BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG LT XL SIZE 3 PMA

    MDR report key: 12405612 · Received September 1, 2021

    Report

    Report Number
    3002806535-2021-00366
    Event Type
    Injury
    Date Received
    September 1, 2021
    Date of Event
    August 24, 2021
    Report Date
    October 14, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279786077
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SUMMARY: AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. X-RAY REVIEW COULD NOT BE PERFORMED DUE TO LOW QUALITY IMAGES. 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 1 COMPLAINT REPORTED WITH THE ITEM 159561,1 COMPLAINT REPORTED WITH THE ITEM 154928 AND 2 COMPLAINTS REPORTED WITH THE ITEM 166576 (INCLUDING THE INITIATING COMPLAINT). WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. CAPA: NO CORRECTIVE OR PREVENTIVE ACTION REQUIRED AT THIS TIME. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00367-1, 3002806535-2021-00368-1. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE SUBMITTED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY ON (B)(6) 2020. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO PAIN IN THE LATERAL COMPONENT WAS PERFORMED ON (B)(6) 2021. DRS ASSESSMENT WAS HE MAY HAVE OVERSTUFFED THE MEDIAL COMPARTMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CONCOMITANT MEDICAL PRODUCTS: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS LOCATION IS UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00367 AND 3002806535-2021-00368. 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 A PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY ON (B)(6) 2020. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO PAIN IN THE LATERAL COMPONENT WAS PERFORMED ON (B)(6) 2021. DRS ASSESSMENT WAS HE MAY HAVE "OVERSTUFFED" THE MEDIAL COMPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307519 OXF ANAT BRG LT XL SIZE 3 PMA OXFORD HXLPE BEARINGS NRA BIOMET UK LTD. N/A 3680208 05019279786077

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R