BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA REVISION TAPERED CEMENTED STEM EXTENSION 13MM DIA +75MM LENGTH

    MDR report key: 17894288 · Received October 9, 2023

    Report

    Report Number
    0001822565-2023-02744
    Event Type
    Injury
    Date Received
    October 9, 2023
    Date of Event
    September 22, 2022
    Report Date
    January 26, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00887868249594
    PMA / PMN Number
    K191625
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6 - COMPONENT CODE - PROPOSED CODE IS MECHANICAL (G04) - STEM. MEDICAL RECORDS PROVIDED CONFIRMED ONGOING PAIN, INSTABILITY, LIGAMENT LAXITY, LIMITATION OF FUNCTION, TISSUE DAMAGE AND INFLAMED SYNOVIUM. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CONCOMITANT DEVICES: PERSONA POSTERIOR STABILIZED ARTICULAR SURFACE LEFT 16MM CATALOG #: 42512600516 LOT #: 64473342, PERSONA POSTERIOR STABILIZED CEMENTED NARROW FEMORAL COMPONENT LEFT SIZE 8 CATALOG #: 42500006401 LOT #: 64983616, PERSONA REVISION CEMENTED TIBIAL COMPONENT LEFT SIZE D CATALOG #: 42542006701 LOT #: 65104608, PERSONA REVISION CEMENTED HALF BLOCK TIBIAL AUGMENT LEFT MEDIAL SIZE CD 5MM CATALOG #: 42555803305 LOT #: 65102646, REFOBACIN BONE CEMENT R 1X40 US CATALOG #: 110034355 LOT #: AZ36AC0107, REFOBACIN BONE CEMENT R 1X40 US CATALOG #: 110034355 LOT #: AZ47BA1511. THE COMPLAINANT HAS NOT YET INDICATED WHETHER THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 3007963827-2023-00268; 3007963827-2023-00269; 0001822565-2023-02744; 0001822565-2023-02745; 0001822565-2023-02746. H3 OTHER TEXT: INVESTIGATION INCOMPLETE.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS LATERAL COLLATERAL LIGAMENT LAXITY INSTABILITY, HAMSTRING TENDON RUPTURE, PAIN AND AMBULATION LIMITATIONS APPROXIMATELY ONE (1) YEAR POST-OPERATIVELY. DURING THE REVISION PROCEDURE, THE PATIENT'S TISSUE WAS IDENTIFIED TO BE DAMAGED WITH INFLAMED SYNOVIUM AND A SYNOVECTOMY WITH DEBRIDEMENT WAS ADDITIONALLY PERFORMED. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. REVISION OPERATIVE NOTES NOTED THE PATIENT WAS REVISED DUE TO INSTABILITY WITH INCREASED LAXITY ON LATERAL THROUGHOUT THE ARC OF MOTION. DURING THE PROCEDURE, TISSUE DAMAGE WITH INFLAMED SYNOVIUM WAS IDENTIFIED. THE SURGEON PERFORMED EXTENSIVE EXCISIONAL DEBRIDEMENT THROUGH FIBRINOUS SUPERFICIAL TISSUE DOWN TO DEEP CAPSULAR TISSUE. THE TIBIAL AND FEMORAL COMPONENTS WERE IDENTIFIED TO BE ALIGNED AND STABLE, BUT THE ARTICULAR SURFACE WAS REVISED AND REPLACED. NO OTHER INTRAOPERATIVE COMPLICATIONS WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1632131 PERSONA REVISION TAPERED CEMENTED STEM EXTENSION 13MM DIA +75MM LENGTH PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 65155265 00887868249594

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention| H SEE H10 NARRATIVE.