BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERF CON TIB BRG LRG 22X60

    MDR report key: 10402760 · Received August 13, 2020

    Report

    Report Number
    0009610576-2020-00008
    Event Type
    Injury
    Date Received
    August 13, 2020
    Date of Event
    June 8, 2020
    Report Date
    January 29, 2021
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    KRR
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D11: ASSOCIATED MEDICAL PRODUCTS. REF. 177284; LOT 2007050790; DESCRIPTION MODULAR TIBIAL TRAY LARGE 76 MM CEMENTED. ADDITIONAL INFORMATION REGARDING THE INVOLVED LOTS DETECTED DURING THE DOCUMENTAL INVESTIGATION.

    Description of Event or Problem · 0

    REVISION DUE TO INSTABILITY, LOOSENING OF FEMALE SCREW, OSTEOLYSIS, POLYESILE METAL DISPOSAL.

    Additional Manufacturer Narrative · 1

    (B)(4). ASSOCIATED MEDICAL PRODUCTS: REF. 177284; LOT 2007060790; DESCRIPTION MODULAR TIBIAL TRAY LGE 76 MM CEMENTED. REF. 7804-07-120; LOT 2007010785; DESCRIPTION ANATOMICAL TIBIAL STEM 14X120X5MM. REF. 7806-16-150; LOT 2007030389; DESCRIPTION FEMORAL STEM 16X150MM W/SCREW . REF. 177043; LOT 05037715; DESCRIPTION PS FEMORAL COMPONENT CLOSED BOX MED LEFT 70 MM CEMENTED. (B)(6). FOREIGN REPORT SOURCE: (B)(6). THIS PRODUCT IS MANUFACTURED BY BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET WARSAW MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K143192. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009610576 - 2020 - 00007 AND 0009610576 - 2020 - 00009.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE (B)(6) PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE IN 2008. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION (B)(6) 2020 DUE TO INSTABILITY OF TOTAL REVISION KNEE PROSTHESIS IMPLEMENTED IN 2008 DUE TO THE BREAKING OF THE CENTRAL STABILIZATION POST OF THE SAME, WITH LOOSENING OF THE FEMALE STEM SCREW, PRESENCE OF MULTIPLE OSTEOLYSIS, POLYESILE METAL DISPOSAL. THE CENTRAL POST WAS FOUND IN THE HOLLOW POPLITEO. RECONSTRUCTION IS NEEDED WITH CONSTRAINED IMPLANT AND INCREASES OF TRABECULAR METAL GIVEN THE LOSS OF SUBSTANCE AND THE AFFECTION OF THE LIG. SIDES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866723 PERF CON TIB BRG LRG 22X60 PROSTHESIS, KNEE KRR BIOMET SPAIN, S.L. N/A 0000151670

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization