BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER OPTION TYPE 1 TPR SLEVE +6

    MDR report key: 8526473 · Received April 18, 2019

    Report

    Report Number
    3002806535-2019-00382
    Event Type
    Injury
    Date Received
    April 18, 2019
    Date of Event
    March 12, 2019
    Report Date
    November 20, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    K082996
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOWING VISUAL, DIMENSIONAL AND ASSEMBLY CHECKS OF THE RETURNED ITEMS, NO DISCREPANCIES HAVE BEEN IDENTIFIED, THEREFORE THE REPORTED EVENT HAS NOT BEEN CONFIRMED. 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

    DURING REVISION CASE WITH AN EXISTING BIOMET MALLORY HEAD AND PF FEMORAL STEM, A TYPE 1 TAPER SLEEVE WOULD NOT SEAT. WE THEN TRIED ANOTHER TYPE 1 TAPER SLEEVE, WHICH ALSO WOULD NOT SEAT. IT WAS VERIFIED WITH ENGINEERS THAT STEM HAD A TYPE 1 TAPER. AFTER IT WAS CONFIRMED THAT THE STEM WAS A TYPE 1 TAPER, THE SURGEON IMPACTED A CERAMIC HEAD ONTO THE STEM.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT:CER OPTION TYPE 1 TPR SLEVE +6, CATALOG #: 650-1068, LOT #:2891919. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00381. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING REVISION CASE WITH AN EXISTING BIOMET MALLORY HEAD AND PF FEMORAL STEM, A TYPE 1 TAPER SLEEVE WOULD NOT SEAT. WE THEN TRIED ANOTHER TYPE 1 TAPER SLEEVE, WHICH ALSO WOULD NOT SEAT. IT WAS VERIFIED WITH ENGINEERS THAT STEM HAD A TYPE 1 TAPER. AFTER IT WAS CONFIRMED THAT THE STEM WAS A TYPE 1 TAPER, THE SURGEON IMPACTED A CERAMIC HEAD ONTO THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323261 CER OPTION TYPE 1 TPR SLEVE +6 HIP PROSTHESIS LZO BIOMET UK LTD. N/A 2946667

    Patients

    Seq Age Sex Outcome Treatment
    1