BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT MD SIZE 4 PMA

    MDR report key: 12196029 · Received July 20, 2021

    Report

    Report Number
    3002806535-2021-00317
    Event Type
    Injury
    Date Received
    July 20, 2021
    Date of Event
    July 13, 2021
    Report Date
    July 28, 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
    WA, US
    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 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 1 COMPLAINT REPORTED WITH THE ITEM 159576(INITIATING COMPLAINT). WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY. CAPA: NO CORRECTIVE OR PREVENTIVE ACTION REQUIRED AT THIS TIME. 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 : UNAVAILABLE BY HOSPITAL POLICY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT PARTIAL KNEE PROCEDURE (B)(6) 2010. SUBSEQUENTLY, PATIENT WAS REVISED (B)(6) 2021 DUE TO POLY WEAR. PATIENT WAS REVISED TO A TOTAL KNEE.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ASSOCIATED ITEMS ONLY: MEDICAL PRODUCT: OXFORD UNI FEMORAL MD, CATALOG #:154601, LOT #:2169331; MEDICAL PRODUCT: OXF UNI TIB TRAY SZ B RM PMA, CATALOG #: 154721, LOT #: 2141617. 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 PATIENT UNDERWENT RIGHT PARTIAL KNEE PROCEDURE (B)(6) 2010. SUBSEQUENTLY, PATIENT WAS REVISED (B)(6) 2021 DUE TO POLY WEAR. PATIENT WAS REVISED TO A TOTAL KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095436 OXF ANAT BRG RT MD SIZE 4 PMA KNEE SYSTEM NRA BIOMET UK LTD. N/A 2115050

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE