BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET BONE CEMENT R 1X40 US

    MDR report key: 11805523 · Received May 11, 2021

    Report

    Report Number
    3006946279-2021-00082
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    April 14, 2021
    Report Date
    September 24, 2021
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LOD
    UDI-DI
    00887868214578
    PMA / PMN Number
    K172408
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CMP-(B)(4). THIS FOLLOW-UP IS TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED : B4, G3, G6, H2, H6, H10 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. NO OTHER COMPLAINT ON MEDICAL: REVISION DUE TO LOOSENING WAS RECORDED ON THE BATCH SINCE EVER, AND 5 OTHER COMPLAINTS ON MEDICAL: REVISION DUE TO LOOSENING WAS RECORDED ON THE REFERENCE FROM APR 1, 2018 TO SEP 23, 2021. ACCORDING TO AVAILABLE DATA, ROOT CAUSE OF THE EVENT WAS UNABLE TO BE 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 A LEFT KNEE ARTHROPLASTY ON (B)(6) 2020. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2021 , DUE TO A LOOSE POROUS STEM AND FEMORAL COMPONENT. DR. (B)(6) REVISED WITH AN OOS FEMUR AND A CEMENTED STEM.

    Additional Manufacturer Narrative · 1

    (B)(4). LIST OF ASSOCIATED DEVICES: NATURAL TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE E, REFERENCE 42532007101, BATCH 64794770; REFERENCE :150464 OSS 3CM DIAPHYSEL SEGMENT LOT : 119830; REFERENCE :150493 OSS REINFORCED YOKE BATCH : 293590; REFERENCE :150477 OSS POLY FEMORAL BUSHINGS 2PK BATCH : 869290; REFERENCE :130615 INTRAMEDULLARY PLUG XL BATCH : 372180; REFERENCE :150480 OSS AXLE BATCH : 171210; REFERENCE :150355 OSS 7CM SEGMENTAL FEMORAL LT BATCH : 188880; REFERENCE :150388 OSS POROUS IM STEM 17.5 X 90 BATCH : 427060; REFERENCE :150476 OSS POLY TIBIAL BUSHING BATCH : 783180; REFERENCE :150411 OSS TIBIAL POLY BEARING 14MM BATCH : 274210; REFERENCE :130613 INTRAMEDULLARY PLUG LGE BATCH : 003670; REFERENCE :150413 OSS TIBIAL POLY BEARING 18MM BATCH : 948210; REFERENCE :150355 OSS 7CM SEGMENTAL FEMORAL LT BATCH : 188940; REFERENCE :150493 OSS REINFORCED YOKE BATCH : 898000; REFERENCE :150477 OSS POLY FEMORAL BUSHINGS 2PK BATCH : 533050; REFERENCE :150480 OSS AXLE BATCH : 826040; REFERENCE :150482 OSS 4CM DIAPHYSEAL SEGMENT BATCH : 289650; REFERENCE :150366 OSS CEMENTED IM STEM 12X150 BATCH : 994210; REFERENCE :150478 OSS POLY LOCK PIN BATCH : 207110. REPORT SOURCE, FOREIGN - HEALTH PROFESSIONAL - EVENT OCCURRED IN UNITED STATES. 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

    IT WAS REPORTED PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY ON (B)(6) 2020. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2021, DUE TO A LOOSEPOROUS STEM AND FEMORAL COMPONENT. DR. (B)(6) REVISED WITH AN OOS FEMUR AND A CEMENTED STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704763 BIOMET BONE CEMENT R 1X40 US ORTHOPAEDIC CEMENT, MEDICATED LOD BIOMET FRANCE S.A.R.L. 927BAA2502 00887868214578

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R