BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CEMENT

    MDR report key: 20890472 · Received December 10, 2024

    Report

    Report Number
    3006946279-2024-00088
    Event Type
    Injury
    Date Received
    December 10, 2024
    Date of Event
    October 11, 2024
    Report Date
    January 21, 2025
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LOD
    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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED DUE TO A MISSING LOT NUMBER. A REVIEW OF THE COMPLAINT HISTORY COULD NOT BE PERFORMED DUE TO MISSING REFERENCE AND LOT NUMBERS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM NUMBER: AVENIR, STEM, STANDARD, CEMENTED, 1, TAPER 12/14; ITEM NAME: 0106010201; LOT# 3173117. ITEM NUMBER: BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14; ITEM NAME: 00877503202; LOT# 3197158. ITEM NUMBER: UNKNOWN CUP/LINER ITEM NAME: UNKNOWN; LOT# UNKNOWN. G2¿FOREIGN¿GERMANY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2534985 UNKNOWN CEMENT BONE CEMENT LOD BIOMET FRANCE S.A.R.L. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H11 NARRATIVE.