BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER OPTION TYPE 1 TPR SLEVE -6

    MDR report key: 9635834 · Received January 28, 2020

    Report

    Report Number
    3002806535-2020-00054
    Event Type
    Injury
    Date Received
    January 28, 2020
    Date of Event
    June 27, 2018
    Report Date
    August 6, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    K082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00053-1. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. 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 THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND NO SIMILAR COMPLAINTS REPORTED WITH THESE ITEMS THE REVIEW OF THE STERILIZATION CERTIFICATE SHOW THAT PRODUCTS RECEIVED ADEQUATE AMOUNT OF RADIATIONS. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. RISK ASSESSMENT: THE EVENT REPORTS REVISION DUE TO UNKNOWN REASON. THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED WITH THE INFORMATION CURRENTLY AVAILABLE, THEREFORE THE SPECIFIC FAILURE CAUSE WITHIN THE RISK TABLES COULD NOT BE SELECTED FOR COMPARISON. AT THIS TIME, NO RISK ASSESSMENT CAN BE CONDUCTED SINCE THE HARM OR REASON FOR REVISION HAS NOT BEEN BE REPORTED. IF FURTHER INFORMATION REGARDING THE ROOT CAUSE OF THE REPORTED EVENT OR REASON FOR REVISION ARE PROVIDED, THE RISK WILL BE RE-ASSESSED. NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE DUE TO UNKNOWN REASONS. THE HEAD AND LINER COMPONENTS WERE REMOVED AND REPLACED. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). UDI# (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: CER BIOLOXD OPTION HD 40MM, CATALOG #: 650-1058, LOT #: 2904573, MEDICAL PRODUCT: E-POLY 40MM +3 MAXROM LNR SZ24, CATALOG #: EP-108424, LOT #: 538330. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00053.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE DUE TO UNKNOWN REASONS. THE HEAD AND LINER COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100921 CER OPTION TYPE 1 TPR SLEVE -6 HIP ARTHROPLASTY LZO BIOMET UK LTD. N/A 2914167

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R