BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI TIB TRAY SZ D RM PMA

    MDR report key: 12406919 · Received September 1, 2021

    Report

    Report Number
    3002806535-2021-00374
    Event Type
    Injury
    Date Received
    September 1, 2021
    Date of Event
    August 24, 2021
    Report Date
    October 13, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279388912
    PMA / PMN Number
    P010014
    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. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, H6, H10. 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. THE SOURCE OF PAIN CANNOT BE DETERMINED THROUGH THE RADIOGRAPHS, AS ONLY AP RADIOGRAPHS PROVIDED, NO ML VIEW SO A FULL ASSESSMENT OF SIZE, POSITION AND ALIGNMENT CANNOT BE DONE. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED, NCR9101 AND NCR006868 WERE ISSUED FOR ITEM 161470 AND NCR0024 WAS ISSUED FOR ITEM 154725. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND 4 COMPLAINTS REPORTED WITH THE ITEM 159583, 5 COMPLAINTS REPORTED WITH THE ITEM 161470 AND 6 COMPLAINTS REPORTED WITH THE ITEM 154725 (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: 3002806535-2021-00372-1, 3002806535-2021-00373-1. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY ON (B)(6), 2016. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO PAIN WAS PERFORMED ON (B)(6), 2021. ATTEMPTS HAVE BEEN MADE BUT NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT: CUSTOMER HAS INDICATED THAT THE PRODUCT HAS BEEN DISCARDED, THEREFORE WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. MEDICAL PRODUCT: OXF TWIN-PEG CMNTD FEM LG PMA, CATALOG #:161470, LOT #: 915290 MEDICAL PRODUCT: OXF ANAT BRG RT LG SIZE 4 PMA, CATALOG #:159583, LOT #: 169240 MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-,00372, 3002806535-2021-00373. 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 RIGHT KNEE ARTHROPLASTY ON (B)(6) 2016. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO PAIN WAS PERFORMED ON (B)(6) 2021. ATTEMPTS HAVE BEEN MADE BUT NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308790 OXF UNI TIB TRAY SZ D RM PMA OXFORD PARTIAL KNEE SYSTEM NRA BIOMET UK LTD. N/A 734830 05019279388912

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R SEE H10 NARRATIVE