BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFOBACIN BONE CEMENT R 1X40G

    MDR report key: 10661317 · Received October 12, 2020

    Report

    Report Number
    3006946279-2020-00201
    Event Type
    Injury
    Date Received
    October 12, 2020
    Date of Event
    February 5, 2019
    Report Date
    February 4, 2021
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    PMA / PMN Number
    K150850
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). WITHIN ALL X-RAYS RECEIVED, ONLY TWO DATED FROM (B)(6) 2019 COULD SHOW THE LOOSENING OF THE FEMORAL STEM. HOWEVER, ONLY THE DISTAL PART OF THE STEM IS SHOWN AND SO IT IS DIFFICULT TO CONFIRM THE IMPLANT LOOSENING THROUGH THOSE X-RAYS. THE PRODUCT ANALYSIS CAN'T BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE DEVICE MANUFACTURING QUALITY RECORD INDICATE THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THE REVIEW OF (B)(4) SHOWS THAT THE FEMORAL STEM USED (OSS CEMENTED IM STEM 13X150, REFERENCE (B)(4)) CAN BE CEMENTED. A COMPLAINT EXTRACT WAS DONE REGARDING REVISION DUE TO LOOSENING: 2 COMPLAINTS (3 PRODUCTS), THIS ONE INCLUDED, HAVE BEEN RECORDED ON REFOBACIN BONE CEMENT R 1X40G, REFERENCE (B)(4), FROM (B)(6) 2017 TO (B)(6) 2021. 1 COMPLAINT (2 PRODUCTS), THIS ONE INCLUDED, HAS BEEN RECORDED ON REFOBACIN BONE CEMENT R 1X40G, REFERENCE (B)(4), BATCH A601DJ1904. ACCORDING TO AVAILABLE DATA, ROOT CAUSE OF THE EVENT WAS UNABLE TO BE DETERMINED. HOWEVER, THERE IS NO EVIDENCE THAT THE EVENT IS RELATED TO THE PRODUCT. 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

    THE PATIENT WAS TREATED FOR A PERIPROSTHETIC FRACTURE IN (B)(6) 2016 INITIALLY. IN (B)(6) 2019 A REVISION FOR ASEPTIC LOOSENING OF THE FEMUR HAD TO BE PERFORMED. A SECOND REVISION HAD TO BE CARRIED OUT ON (B)(6) 2020 FOR A NEW REMOVAL OF THE FEMORAL COMPONENT BECAUSE OF ASEPTIC LOOSENING. THIS COMPLAINT HANDLES THE FIRST REVISION SURGERY WHICH OCCURED ON (B)(6) 2019.

    Additional Manufacturer Narrative · 1

    (B)(4). LIST OF ASSOCIATED DEVICES: OSS POLY TIBIAL BUSHING, REFERENCE 150476, BATCH 678220; OSS MOD TIB BASEPLATE 79MM, REFERENCE 150424, BATCH 811420; OSS CEMENTED IM STEM 13MMX90MM, REFERENCE 150362, BATCH 169330; BIOMET ARCOM AP PATELLA 34MM, REFERENCE 11-150822, BATCH 801050; OSS AXLE, REFERENCE 150480, BATCH 936720; OSS POLY FEMORAL BUSHINGS 2PK, REFERENCE 150477, BATCH 166910; OSS REINFORCED YOKE, REFERENCE 150493, BATCH 190020; OSS 7CM SEGMENTAL FEMORAL RT, REFERENCE 150354, BATCH 171250; OSS POLY LOCK PIN, REFERENCE 150478, BATCH 879820; OSS 3CM ELLIP DIAPHYSEAL SEG, REFERENCE 150461, BATCH 627580; OSS CEMENTED IM STEM 13X150, REFERENCE 150367, BATCH 379450; OSS POLY FEMORAL BUSHINGS 2PK, REFERENCE 150477, BATCH 420580. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    THE PATIENT WAS TREATED FOR A PERIPROSTHETIC FRACTURE IN (B)(6) 2016 INITIALLY. IN (B)(6) 2019 A REVISION FOR ASEPTIC LOOSENING OF THE FEMUR HAD TO BE PERFORMED. A SECOND REVISION HAD TO BE CARRIED OUT ON (B)(6) 2020 FOR A NEW REMOVAL OF THE FEMORAL COMPONENT BECAUSE OF ASEPTIC LOOSENING. THIS COMPLAINT HANDLE THE FIRST REVISION SURGERY WHICH OCCURED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1127000 REFOBACIN BONE CEMENT R 1X40G BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. A601DJ1904

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 2 PRODUCTS BATCH A601DJ1904 USED.| ASSOCIATED DEVICES LISTED.