BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 40MM

    MDR report key: 11365257 · Received February 23, 2021

    Report

    Report Number
    3002806535-2021-00043
    Event Type
    Injury
    Date Received
    February 23, 2021
    Date of Event
    January 15, 2021
    Report Date
    March 1, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    UDI-DI
    00887868248597
    PMA / PMN Number
    K192683
    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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT 3002806535-2021-00044-01. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED. 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 COMPLAINT HISTORY WAS ASSESSED FOR THREE YEARS PRIOR TO THE NOTIFICATION DATE AND IDENTIFIED (9) TOTAL COMPLAINTS FOR ITEM 650-1058. THERE WERE (0) ADDITIONAL COMPLAINTS AGAINST THE LOT 2993794. A REVIEW OF COMPLAINT HISTORY WAS ASSESSED FOR THREE YEARS PRIOR TO THE NOTIFICATION DATE AND IDENTIFIED (4) TOTAL COMPLAINTS FOR ITEM 650-1067. THERE WERE (0) ADDITIONAL COMPLAINTS AGAINST THE LOT 3031101. NO TRENDS WERE IDENTIFIED FROM COMPLAINT HISTORY REVIEW FOR THE ITEMS 650-1067. FOR THE ITEM 650-1058, 2 COMPLAINTS WERE REPORTED WITH SAME HOSPITAL. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, THE ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY. RISK ASSESSMENT: THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED WITH THE INFORMATION CURRENTLY AVAILABLE, THEREFORE THE SPECIFIC FAILURE CAUSE WITHIN THE RISK TABLE COULD NOT BE SELECTED FOR COMPARISON. THE REPORTED EVENT STATES THAT THE REVISION WAS PERFORMED DUE TO INFECTION. ALTHOUGH THE ROOT CAUSE COULD NOT BE DETERMINED, INFECTION IS CAPTURED MULTIPLE TIMES WITHIN THE CERAMICS HEAD RISK TABLE WITH A SEVERITY SCORE NO GREATER THAN 3 (MODERATE). THE OUTCOME OF THIS COMPLAINT (SURGICAL INTERVENTION) IS CONSIDERED TO BE WITHIN THE SEVERITY OF THE RMF. IF FURTHER INFORMATION REGARDING THE ROOT CAUSE OF THE REPORTED EVENT IS PROVIDED, RISK SHOULD BE RE-ASSESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL HIP PROCEDURE ON (B)(6) 2019. THE PATIENT HAS SINCE RECEIVED MULTIPLE REVISION PROCEDURES. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO INFECTION WAS PERFORMED ON (B)(6) 2021. THE REVISED IMPLANTS WERE IMPLANTED ON (B)(6) 2020. NO FURTHER INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT# 650-1067 CER OPTION TYPE 1 TPR SLEVE +3 LOT# 3031101. CAT# 30124009 G7 VIT E HIGH WALL LNR 40MM I LOT#64714864. CAT# 110010271 G7 OSSEOTI MULTIHOLE 66MM I LOT# R3713970A. CAT#11-300817 ARCOS 17X150MM SPL TPR DIST LOT#838140 CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00044.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 11 MONTHS POST IMPLANTATION DUE TO AN INFECTION. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263656 CER BIOLOXD OPTION HD 40MM HIP PROTHESIS LPH BIOMET UK LTD. N/A 2993794 00887868248597

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R