BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI TIB TRAY SZ F RM PMA

    MDR report key: 9693751 · Received February 11, 2020

    Report

    Report Number
    3002806535-2020-00074
    Event Type
    Injury
    Date Received
    February 11, 2020
    Date of Event
    January 13, 2020
    Report Date
    February 20, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HWA
    PMA / PMN Number
    P01004
    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 REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. . D11: MEDICAL PRODUCT: OXF ANAT BRG RT LG SIZE 3 PMA, CATALOG#: 159582, LOT#: 825700. MEDICAL PRODUCT: OXF TWIN-PEG CMNTD FEM LG PMA, CATALOG#: 161470, LOT#: 700850. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00072-1, 3002806535-2020-00073-1. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE PAIN WITHOUT SURGICAL NOTES, POST-PRIMARY X-RAYS AND PATIENT INFORMATION SUCH AS ACTIVITY LEVELS AND BMI, THEREFORE THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED. THE OUTCOME OF THIS COMPLAINT IS CONSIDERED TO BE WITHIN THE SEVERITY OF THE RMR. THE MANUFACTURING HISTORY RECORDS (MHRS) FOR THE OXFORD PARTIAL KNEE FEMORAL COMPONENT, TIBIAL TRAY AND ANATOMICAL BEARING HAVE BEEN CHECKED AND VERIFY THAT THE COMPONENTS WERE MANUFACTURED AND STERILISED IN ACCORDANCE WITH THE APPLICABLE SPECIFICATIONS. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND 1 SIMILAR COMPLAINT FOR THIS ITEM CODE 159582, 2 SIMILAR COMPLAINTS FOR THIS ITEM CODE 161470 AND NO SIMILAR COMPLAINTS FOUND FOR THE ITEM 154776. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO PAIN.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: OXF TWIN-PEG CMNTD FEM LG PMA, CATALOG #: 161470 LOT #: 700850, MEDICAL PRODUCT: ANAT BRG RT LG SIZE 3 PMA, CATALOG #: 159582, LOT #: 825700. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00073, 3002806535-2020-00072. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159379 OXF UNI TIB TRAY SZ F RM PMA KNEE PROTHESIS HWA BIOMET UK LTD. N/A 464000

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R