BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER OPTION TYPE 1 TPR SLEVE -3

    MDR report key: 11955629 · Received June 8, 2021

    Report

    Report Number
    3002806535-2021-00242
    Event Type
    Injury
    Date Received
    June 8, 2021
    Date of Event
    February 26, 2019
    Report Date
    July 1, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    OQG
    UDI-DI
    00880304521940
    PMA / PMN Number
    K192683
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 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 1 COMPLAINT REPORTED WITH THE ITEMS (B)(4) AND (B)(4) (INITIATING COMPLAINT). WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. 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 REPORTS: 3002806535-2021-00241-1. 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. H3 OTHER TEXT : REMAINS IMPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INITIAL RIGHT TOTAL HIP ARTHROPLASTY PERFORMED (B)(6) 2018. SUBSEQUENTLY, THE PATIENT UNDERWENT SCREW REMOVAL AND HEAD AND LINER EXCHANGE ON (B)(6) 2019 DUE TO SCREW MIGRATION. APPROXIMATELY ONE MONTH LATER, THE PATIENT DEVELOPED A SUPERFICIAL INFECTION AT THE INCISION SITE. SUPERFICIAL IRRIGATION AND DEBRIDEMENT WAS PERFORMED ON (B)(6) 2019. NO PRODUCT WAS EXCHANGED AS THE INFECTION DID NOT PENETRATE THE JOINT SPACE.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. MEDICAL PRODUCT: CER BIOLOXD OPTION HD 40MM, CATALOG #: 650-1058, LOT #: 2948783. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535-2021-00241. 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 THE INITIAL RIGHT TOTAL HIP ARTHROPLASTY PERFORMED (B)(6) 2018. SUBSEQUENTLY, THE PATIENT UNDERWENT SCREW REMOVAL AND HEAD AND LINER EXCHANGE ON (B)(6) 2019 DUE TO SCREW MIGRATION. APPROXIMATELY ONE MONTH LATER, THE PATIENT DEVELOPED A SUPERFICIAL INFECTION AT THE INCISION SITE. SUPERFICIAL IRRIGATION AND DEBRIDEMENT WAS PERFORMED ON (B)(6) 2019. NO PRODUCT WAS EXCHANGED AS THE INFECTION DID NOT PENETRATE THE JOINT SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850874 CER OPTION TYPE 1 TPR SLEVE -3 HIP ARTHROPLASTY OQG BIOMET UK LTD. N/A 2948118 00880304521940

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention SEE H10.