BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NON-POROUS PERF TIB TRAY-LGE

    MDR report key: 10402752 · Received August 13, 2020

    Report

    Report Number
    0009610576-2020-00007
    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. 178892; LOT 0000151670; DESCRIPTION PS CONSTRAINED INSERT LGE 22MM W/SCREW. 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. (B)(4); LOT 151670; DESCRIPTION PS CONSTRAINED INSERT LGE 22MM W/SCREW. REF. (B)(4); LOT 2007010785; DESCRIPTION ANATOMICAL TIBIAL STEM 14X120X5MM. REF. (B)(4); LOT 2007030389; DESCRIPTION FEMORAL STEM 16X150MM W/SCREW . REF. (B)(4); LOT 05037715; DESCRIPTION PS FEMORAL COMPONENT CLOSED BOX MED LEFT 70 MM CEMENTED. REPORTER: (B)(6). FOREIGN REPORT SOURCE: (B)(6). THIS PRODUCT IS MANUFACTURED BY (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) 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 - 00008 AND 0009610576 - 2020 - 00009.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE (B)(6) AGENCY OF MEDICINES AND MEDICAL DEVICES 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
    866716 NON-POROUS PERF TIB TRAY-LGE PROSTHESIS, KNEE KRR BIOMET SPAIN, S.L. N/A 2007050790

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization