BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 32/0, TAPER 12/14

    MDR report key: 20613855 · Received November 5, 2024

    Report

    Report Number
    0009613350-2024-00521
    Event Type
    Injury
    Date Received
    November 5, 2024
    Date of Event
    October 11, 2024
    Report Date
    February 20, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024430327
    PMA / PMN Number
    K200112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM#: 0106010201, AVENIR®, STEM, STANDARD, CEMENTED, 1, TAPER 12/14, TAPER 12/14, LOT#: 3173117. ITEM#: UNKNOWN, UNKNOWN CUP/LINER, LOT#: UNKNOWN. G2: REPORT SOURCE GERMANY. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4): THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: ITEM # 0106010201, AVENIR®, STEM, STANDARD, CEMENTED, 1, TAPER 12/14, TAPER 12/14, LOT # 3173117. ITEM # UNKNOWN, UNKNOWN CUP/LINER, LOT # UNKNOWN. ITEM # UNKNOWN, UNKNOWN CEMENT, LOT # UNKNOWN. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. DEVICES ARE USED FOR TREATMENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. DUE TO INSUFFICIENT PRODUCT INFORMATION ON THE LINER, THE COMPATIBILITY OF THE INVOLVED PRODUCTS COULD NOT BE VERIFIED. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. COMPLAINTS ARE MONITORED IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. MEDICAL RECORDS WERE NOT PROVIDED. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CANNOT BE CONFIRMED. THE CONTRIBUTING FACTORS THAT LEAD TO THE INTRAOPERATIVE ISSUE ARE MULTIPLE: EITHER THE HEAD AND THE STEM COULD NOT BE DISENGAGE FROM EACH OTHER, LEADING TO THE LOOSENING OF THE STEM FROM THE CEMENT MANTLE AT THE MOMENT OF THE IMPACTION ON THE HEAD; OR THE MANTLE AND THE STEM WERE ALREADY LOOSE, THEREFORE THE STEM CAME OUT EVEN WITH MINIMAL IMPACTION ON THE HEAD. WITH THE AVAILABLE INFORMATION NEITHER THE ROOT CAUSE OF THE DISLOCATION, NEITHER THE ROOT CAUSE FOR THE INTRAOPERATIVE CAN BE DEFINITIVELY DETERMINED. 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 PATIENT UNDERWENT HIP REVISION APPROXIMATELY 21 DAYS POST IMPLANTATION DUE TO A DISLOCATION CAUSED BY A FALL IN THE DOMESTIC ENVIRONMENT. DURING THE INTRAOPERATIVE ATTEMPT TO DETACH THE HEAD FROM THE STEM, THE HEAD AND STEM CAME OUT OF THE MEDULLARY CAVITY OF THE FEMUR AFTER THE THIRD STROKE. AS A RESULT, THE MEDULLARY CANAL HAD TO BE PARTIALLY FREED FROM THE CEMENT IN ORDER TO BE ABLE TO PLACE A NEW STEM INCLUDING A NEW THIN CEMENT MANTLE AND A HEAD WITH MORE OFFSET HAD TO BE IMPLANTED. DELAY 60 MINUTES FOR COMPLEX PARTIAL REMOVAL OF THE CEMENT IN THE FEMUR TO MAKE ROOM FOR RE-IMPLANTATION AND PARTIAL NEW CEMENT MANTLE, TRIAL REDUCTION, RE-IMPLANTATION INCLUDING HARDENING OF THE CEMENT, REDUCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461743 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 32/0, TAPER 12/14 PROSTHESIS, HIP LZO ZIMMER GMBH N/A 3197158 00889024430327

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H11 NARRATIVE.| SEE H11 NARRATIVE.