BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD FEMORAL COMPONENT

    MDR report key: 11775649 · Received May 5, 2021

    Report

    Report Number
    3002806535-2021-00154
    Event Type
    Injury
    Date Received
    May 5, 2021
    Report Date
    May 19, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535-2021-00153-2. 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

    JOURNAL ARTICLE: FEMORAL MIGRATION OF THE CEMENTLESS OXFORD WHICH CAUSED THE BEARING DISLOCATION BY HIROSHI INUI , SHUJI TAKETOMI , RYOTA YAMAGAMI , KOHEI KAWAGUCHI , SAKAE TANAKA. CASE REPORT: IN AN 82-YEAR-OLD WOMAN, BEARING DISLOCATION OCCURRED 13 MONTHS POSTOPERATIVELY BECAUSE OF FEMORAL MIGRATION THAT WAS RESOLVED WITH AN REVISION SURGERY TO CEMENTED COMPONENT AND THICKER MOBILE INSERT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: ASSOCIATE PRODUCT: MEDICAL PRODUCT: UNK OXFORD BEARING, CATALOG #: UNKNOWN, LOT #: UNKNOWN; MEDICAL PRODUCT: UNK OXFORD TIBIAL COMPONENT, CATALOG #: UNKNOWN, LOT #: UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00153-1. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    JOURNAL ARTICLE: FEMORAL MIGRATION OF THE CEMENTLESS OXFORD WHICH CAUSED THE BEARING DISLOCATION BY HIROSHI INUI, SHUJI TAKETOMI, RYOTA YAMAGAMI, KOHEI KAWAGUCHI, SAKAE TANAKA. CASE REPORT: AN 82-YEAR-OLD WOMAN, BEARING DISLOCATION OCCURRED 13 MONTHS POSTOPERATIVELY BECAUSE OF FEMORAL MIGRATION THAT WAS RESOLVED WITH AN REVISION SURGERY TO CEMENTED COMPONENT AND THICKER MOBILE INSERT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672025 UNKNOWN OXFORD FEMORAL COMPONENT OXFORD PARTIAL KNEE SYSTEM NRA BIOMET UK LTD. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R