BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 36MM

    MDR report key: 8649494 · Received May 29, 2019

    Report

    Report Number
    3002806535-2019-00469
    Event Type
    Injury
    Date Received
    May 29, 2019
    Date of Event
    April 2, 2019
    Report Date
    September 14, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G4, G7, H1, H2, H6, H10. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT PRIMARY LEFT THA. SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL APPROXIMATELY 2 MONTHS POST IMPLANTATION DUE TO INFECTION WHERE PATIENT UNDERWENT A TWO-STAGE REVISION SECONDARY TO THE PRESENCE OF MRSA.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET TAPER SLEEVE: ITEM # 650-1064/LOT # 2955104. BIOMET STEM: ITEM # 192808/LOT # 668350. ZIMMER BONE SCREW: ITEM # 00625006530/LOT # 64228001. BIOMET LINER: ITEM # 010000817/LOT # 6354149. BIOMET SHELL: ITEM # 010000662/LOT # 6395394. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535-2019-00470. 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 THE PATIENT UNDERWENT PRIMARY LEFT THA. SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL APPROXIMATELY 2 MONTHS POST IMPLANTATION DUE TO INFECTION WHERE PATIENT UNDERWENT A TWO-STAGE REVISION SECONDARY TO THE PRESENCE OF (B)(6). ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443450 CER BIOLOXD OPTION HD 36MM HIP PROSTHESIS LZO BIOMET UK LTD. N/A 2955098

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEEH10.