BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK OXFORD BEARING COMPONENT

    MDR report key: 11776773 · Received May 5, 2021

    Report

    Report Number
    3002806535-2021-00159
    Event Type
    Injury
    Date Received
    May 5, 2021
    Report Date
    May 20, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HRY
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SUMMARY: BIOMET UK LTD HAVE ATTEMPTED TO CONTACT THE JOURNAL ARTICLE AUTHOR, HOWEVER, NO ADDITIONAL INFORMATION IS RECEIVED. THE PRODUCT HAS NOT BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION, THEREFORE, A THOROUGH INVESTIGATION HAS NOT BEEN POSSIBLE. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. THE ITEM NUMBER AND LOT NUMBER IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY AND THE COMPLAINT HISTORY WAS NOT PROVIDED. THE JOURNAL ARTICLE BELIEVES THAT THE REASON FOR THE FAILURE WAS OSTEOPOROSIS AND EARLY RETURN TO HIGH PERFORMANCE ACTIVITY. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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 : ITEM NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    THE EVENT REPORTS REVISION DUE TO DISLOCATION. IN A 52-YEAR-OLD MAN, FIRST BEARING DISLOCATION OCCURRED 7 MONTHS POSTOPERATIVELY. FIVE MONTHS AFTER REVISING THE INSERT TO A THICKER ONE, ANOTHER DISLOCATION OCCURRED MAINLY BECAUSE OF THE FEMORAL MIGRATION. EVENTUALLY, A REVISION TO TOTAL KNEE ARTHROPLASTY WAS NECESSARY. THIS COMPLAINT IS FOR THE 1ST REVISION DUE TO DISLOCATION.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. CONCOMITANT MEDICAL PRODUCTS: THE PRODUCT HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE EVENT REPORTS REVISION DUE TO DISLOCATION. IN A(B)(6) YEAR-OLD MAN, FIRST BEARING DISLOCATION OCCURRED 7 MONTHS POSTOPERATIVELY. FIVE MONTHS AFTER REVISING THE INSERT TO A THICKER ONE, ANOTHER DISLOCATION OCCURRED MAINLY BECAUSE OF THE FEMORAL MIGRATION. EVENTUALLY, A REVISION TO TOTAL KNEE ARTHROPLASTY WAS NECESSARY. THIS COMPLAINT IS FOR THE 1ST REVISION DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672829 UNK OXFORD BEARING COMPONENT KNEE ARTHROPLASTY HRY BIOMET UK LTD. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R