BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSO KNEE BONE SUBSTITUTION

    MDR report key: 8801638 · Received July 18, 2019

    Report

    Report Number
    0009610576-2019-00012
    Event Type
    Injury
    Date Received
    July 18, 2019
    Report Date
    July 17, 2019
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    KRO
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: AXLE 30 MM PSO KNEE REF. 1520-34, LOT 2008091292. CIRCLIP PSO KNEE REF. 1520-22, LOT 2009070978. STRAIGHT STEM 12X250MM REF. 1528-33, LOT 03081325. STRAIGHT STEM REF. 1528-60, LOT 2008011263. FEMORAL PRIMARY COMPONENT 64MM LEFT MED. REF. 1521-11, LOT 02093477. PMA/510K #: THIS PRODUCT IS MANUFACTURED BY BIOMET (B)(4) ORTHOPAEDICS, (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) NUMBERS K945028 AND K974558. THE MANUFACTURING SITE HAS CHANGED. EVENT PREVIOUSLY SUBMITTED THROUGH MEDWATCH # 0001825034-2019-02313. DEVICE EVALUATED BY MFR: REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL LEFT KNEE ARTHROPLASTY ON UNKNOWN DATE IN (B)(6) 2010. SUBSEQUENTLY, THE PMI GROUP IS REQUESTING A CUSTOM IMPLANT TO REVISE THE PSO PROSTHESIS ON (B)(6) 2019 DUE POLYETHYLENE WEAR. THE REVISION SURGERY IS PLANNED FOR THE END OF (B)(6) OR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595473 PSO KNEE BONE SUBSTITUTION KNEE PROSTHESIS KRO BIOMET SPAIN, S.L. N/A 2008041370

    Patients

    Seq Age Sex Outcome Treatment
    1 Other