BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LCCK ARTICULAR SURFACE WITH LOCKING SCREW

    MDR report key: 6927167 · Received October 7, 2017

    Report

    Report Number
    0001822565-2017-06838
    Event Type
    Injury
    Date Received
    October 7, 2017
    Date of Event
    September 6, 2017
    Report Date
    December 8, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK960279
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. REVIEW OF THE X-RAY BY RADIOLOGISTS INDICATES THAT THERE IS A DISLODGED SCREW IN THE ANTERIOR JOINT RECESS, IN THE REGION OF HOFFA'S FAT PAD, BASED ON LOCALIZATION MADE ON THE LATERAL VIEW. THE REMAINDER OF THE IMAGED HARDWARE APPEARS INTACT. NO PERIPROSTHETIC LUCENCY IS IDENTIFIED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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 · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - NEXGEN PS PRE STEM TIBIA PLATE #00-5980-047-02, LOT #63381030. NEXGEN LCCK FEM IMPLANT #00-5994-017-91, LOT #62873816. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF ARTICULAR SURFACE APPROXIMATELY 1 YEAR POST INITIAL KNEE PROCEDURE AS THE LOCKING SCREW BACKED OUT. THE SURGEON USED A TORQUE WRENCH TO ENSURE THE SCREW WAS PROPERLY SEATED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707073 NEXGEN LCCK ARTICULAR SURFACE WITH LOCKING SCREW PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 61139131

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R