BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFOBACIN REVISION 40 -3

    MDR report key: 20449718 · Received October 15, 2024

    Report

    Report Number
    3006946279-2024-00072
    Event Type
    Injury
    Date Received
    October 15, 2024
    Date of Event
    April 28, 2022
    Report Date
    October 25, 2024
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    UDI-DI
    04040029922675
    PMA / PMN Number
    K171540
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM# 211235; LOT# 602750; ITEM NAME# COMPR SRS MOD STEM - 6X100MM ITEM# 211218; LOT# 179220; ITEM NAME# COMPR SRS PROX BDY - LG 42MM ITEM# 211225; LOT# 284100; ITEM NAME# COMPR SRS IC SEG - 60MM ITEM# 211228; LOT# 725920; ITEM NAME# COMPR SRS MOD RGX AUG - SM ITEM# 115365; LOT# 793660; ITEM NAME# COMP RVS TI TRAY +5MM 44MM ITEM# EP-115398; LOT# 699030; ITEM NAME# E1 44-41 RTNV +3 HMRL BRG ITEM# 115330; LOT# 527560; ITEM NAME# COMP RVRS SHDR GLEN BSPLT +HA ITEM# TI-115320; LOT# 387210; ITEM NAME# COMP VRSDL GLNSPR 41MM TI. G2- DENMARK 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.

    Additional Manufacturer Narrative · 0

    (B)(4) THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW IDENTIFIED NO CONTRIBUTING FACTORS TO THE REPORTED EVENT. SHORT SURGICAL REPORT FROM THE REVISION SURGERY ONLY STATES THAT THE HUMERUS STEM WAS LOOSE, AND A NEW ONE WAS IMPLANTED. SO, THERE ARE NO CONTEMPLATIONS ON WHY THE LOOSENING HAPPENED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM A CLINICAL STUDY THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO MIGRATION OR LOOSENING OF THE HUMERAL STEM. THE GLENOID COMPONENTS REMAINED INTACT, AND ALL OTHER COMPONENTS WERE REVISED, APPROXIMATELY 1 YEAR AND 5 MONTHS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

    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
    37651 REFOBACIN REVISION 40 -3 ORTHOPAEDIC BONE CEMENT, MEDICATED MBB BIOMET FRANCE S.A.R.L. N/A 936CAA2506 04040029922675

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention| H SEE H10 NARRATIVE