BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POSTERIOR STABILIZED OPEN BOX FEMORAL COMPONENT LEFT 72.5MM

    MDR report key: 8451837 · Received March 26, 2019

    Report

    Report Number
    0001825034-2019-01409
    Event Type
    Injury
    Date Received
    March 26, 2019
    Date of Event
    March 4, 2019
    Report Date
    November 27, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT SAMPLE WAS EVALUATED THROUGH PHOTOGRAPHIC INSPECTION, HOWEVER, THE REPORTED EVENT COULD NOT BE CONFIRMED. PHOTOGRAPHS OF THE DEVICES EXHIBITED NICKS/SCRATCHES ON THE SURFACE OF THE TIBIAL BEARING WITH BLOOD/TISSUE RESIDUE ON THE SURFACE. THE FEMORAL COMPONENT EXHIBITED A DENT ON THE PROXIMAL EDGE AND BLOOD/TISSUE RESIDUE WAS ALSO FOUND ON THE INNER SURFACE AND FEMORAL PEGS. RADIOGRAPHIC INSPECTION SHOWED NO EVIDENCE OF ABNORMAL RADIOLUCENCY OR COMPONENT LOOSENING AND THE COMPONENTS APPEARED TO BE ANATOMICALLY ALIGNED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). UDI # - (B)(4). CONCOMITANT MEDICAL PRODUCTS ¿ POSTERIOR STABILIZED TIBIAL BEARING 10MM X 71/75MM CATALOG #: 183640 LOT #: 678370, VANGUARD DISTAL FEMORAL PEG CATALOG #: 183099 LOT #: 918870, BIOMET SERIES A STANDARD PATELLA 3 PEG 31MM CATALOG #: 184764 LOT #: 230590, BIOMET POLISHED FINNED TIBIAL TRAY 75MM CATALOG #: 141254 LOT #: 2016050094. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT; PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 0001825034-2019-01410, 0001825034-2019-01411. INVESTIGATION INCOMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN, STIFFNESS, LIMITED RANGE OF MOTION AND TIBIAL COMPONENT LUCENCY. THE FEMORAL COMPONENT APPEARED TO BE WELL FIXED, HOWEVER, THE TIBIAL COMPONENT WAS FOUND TO BE LOOSE INTRAOPERATIVELY. ALL COMPONENTS WERE REMOVED AND REPLACED EXCEPT THE PATELLA, WHICH WAS INTACT AND LEFT IMPLANTED. IT WAS ADDITIONALLY NOTED THAT THE SURGEON BELIEVED THERE WERE SEVERAL POTENTIAL CAUSES FOR THE PATIENT¿S SYMPTOMS AND NOT SOLELY RELATED TO THE TIBIAL COMPONENT LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244138 POSTERIOR STABILIZED OPEN BOX FEMORAL COMPONENT LEFT 72.5MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 478460

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R