BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TNBN POL COCR FIN TIB TRAY 67

    MDR report key: 12274258 · Received August 4, 2021

    Report

    Report Number
    0009610576-2021-00008
    Event Type
    Injury
    Date Received
    August 4, 2021
    Date of Event
    October 1, 2012
    Report Date
    September 23, 2021
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    KRO
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ASSOCIATED PRODUCTS: CR-INTERLOK FEMUR ANATOMIC RIGHT 62,5MM TITAN NIOB REF. (B)(4) LOT UNK; DCM CR 10MM X 63/67MM REF. (B)(4) LOT UNK. G4: THIS PRODCUT IS MANUFACTURED BY BIOMET SAPIN ORTHOPAEDICS, S.L. 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 K945028. ADDITIONAL INFORMATION RECEIVED: REF. (B)(4); LOT.UNK. THE COMPLAINT IS GOING TO BE CLOSED DUE TO THE LACK OF INFORMATION (LOT NUMBER HAS NOT BEEN PROVIDED AND PRODUCT HAS NOT BEEN RETURNED). THEREFORE, IT HAS NOT BEEN POSSIBLE TO PERFORM AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED ACCORDINGLY, AND SUBSEQUENTLY A SUPPLEMENTAL REPORT WILL BE PROVIDED WHERE DEEMED REQUIRED. H3 OTHER TEXT: REMAINS IMPLANTED.

    Description of Event or Problem · 0

    CLINICAL STUDY REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, THE PATIENT EXPERIENCED SWELLING AND DECREASED MOBILITY OF THE OPERATED KNEE. KNEE MOBILIZATION WAS PERFORMED UNDER ANAESTHESIA ON (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CR-INTERLOK FEMUR ANATOMIC RIGHT 62,5MM TITAN NIOB, REF. 183006TNBN, LOT UNK. DCM CR 10MM X 63/67MM, REF. UNK, LOT UNK. REPORT SOURCE: THIS PRODCUT IS MANUFACTURED BY BIOMET SAPIN ORTHOPAEDICS, S.L. 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 K945028. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    CLINICAL STUDY REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, THE PATIENT EXPERIENCED SWELLING AND DECREASED MOBILITY OF THE OPERATED KNEE. KNEE MOBILIZATION WAS PERFORMED UNDER ANAESTHESIA ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170979 TNBN POL COCR FIN TIB TRAY 67 PROSTHESIS KNEE KRO BIOMET SPAIN, S.L. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other SEE H10