BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLISHED FINNED TIB TRAY 67MM

    MDR report key: 10640473 · Received October 7, 2020

    Report

    Report Number
    0009610576-2020-00011
    Event Type
    Injury
    Date Received
    October 7, 2020
    Date of Event
    September 8, 2020
    Report Date
    January 21, 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
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D11: ASSOCIATED MEDICAL PRODUCTS: REF. (B)(4); LOT 807AA07130; DESCRIPTION OPTIP 40 REFOB PLUS BONE CMT-3. REF. (B)(4); LOT J6383160; DESCRIPTION VANGUARD CR ILOK FEM-RT 60. G3: FOREIGN. THE EVENT OCCURRED IN PORTUGAL. G5: THIS PRODUCT IS MANUFACTURED BY BIOMET SPAIN 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. H3: PRODUCT NOT RETURNED. PRODUCT NOT RETURNED YET.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY WITH CEMENTED VANGUARD IMPLANTS, USING THE SIGNATURE SURGICAL TECHNIQUE. ALL STEPS HAVE BEEN STRICTLY ACCOMPLISHED. IN THE POST-SURGERY FOLLOW-UP CONSULTATION, AFTER 17 MONTHS, THE PATIENT HAD PAIN AND JOINT EFFUSION, AND A DETACHMENT OF THE TIBIAL COMPONENT WAS DETECTED BY X-RAY.

    Additional Manufacturer Narrative · 1

    (B)(4). ASSOCIATED MEDICAL PRODUCTS: REF. (B)(4); LOT 807AA07130; DESCRIPTION OPTIP 40 REFOB PLUS BONE CMT-3; REF. (B)(4); LOT J6383160; DESCRIPTION VANGUARD CR ILOK FEM-RT 60. FOREIGN. THE EVENT OCCURRED IN (B)(6). THIS PRODUCT IS MANUFACTURED BY BIOMET SPAIN 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. PRODUCT NOT RETURNED YET, REVISION SURGERY SCHEDULED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY WITH CEMENTED VANGUARD IMPLANTS, USING THE SIGNATURE SURGICAL TECHNIQUE. ALL STEPS HAVE BEEN STRICTLY ACCOMPLISHED. IN THE POST-SURGERY FOLLOW-UP CONSULTATION, AFTER 17 MONTHS, THE PATIENT HAD PAIN AND JOINT EFFUSION, AND A DETACHMENT OF THE TIBIAL COMPONENT WAS DETECTED BY X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108231 POLISHED FINNED TIB TRAY 67MM PROTHESIS, KNEE KRO BIOMET SPAIN, S.L. N/A 2018111201

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization SEE H10 NARRATIVE