BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD COMPLETE KNEE SYSTEM XP-XP TIBIAL TRAY 67MM ¿ INTERLOK LOCKING BAR & CE

    MDR report key: 6138473 · Received December 1, 2016

    Report

    Report Number
    0001825034-2016-04966
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    November 2, 2016
    Report Date
    March 14, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    PK132873
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. DESCRIBE EVENT OR PROBLEM UPDATED.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. UDI#: (B)(4). EXPLANT DATE: - THE LOCKING BAR IS PACKAGED AS A COMPONENT OF THE TIBIAL TRAY; THE LOCKING BAR WAS REMOVED AND REPLACED BUT THE TIBIAL TRAY REMAINS IMPLANTED. CONCOMITANT PRODUCT(S):- VANGUARD LATERAL TIBIAL BEARING 9X63, CATALOG 195807, LOT 894220; VANGUARD MEDIAL TIBIAL BEARING 9X63, CATALOG 195877, LOT 165880; SERIES A PATELLA,, CATALOG 184764, LOT 899960; VANGUARD LEFT FEMUR 65MM, CATALOG 195922, LOT 426860. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, "LOOSENING, MIGRATION, OR FRACTURE OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, MALPOSITION, NON-UNION, BONE RESORPTION AND/OR EXCESSIVE UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY AND/OR EXCESSIVE WEIGHT." NUMBER 15 STATES, "INTEROPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN."

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED PARTS IDENTIFIED PITTING AND WEAR ON THE ARTICULAR SURFACE OF THE BEARINGS, LIKELY CAUSE BY A THIRD BODY. THE MEDIAL BEARING ALSO HAS GOUGES BY THE LOCKING BAR SLOT POSSIBLY CAUSED BY THE LOCKING BAR INSERTER TOOL DURING THE INITIAL PROCEDURE. EXAMINATION OF THE LOCKING BAR IDENTIFIED ABRASIONS WHICH WERE LIKELY CAUSED BY THE INSERTION AND REMOVAL OF THE LOCKING BAR. A CLOSER LOOK AT THE HOOK ON THE LOCKING BAR DID NOT IDENTIFY ANY WEAR OR MARKINGS TYPICALLY FOUND ON THE LOCKING BAR WHEN IT IS WELL FIXED. REVIEW OF THE PROVIDED PICTURES ON THE ASSOCIATED COMPLAINT CONFIRMS THE COMPLAINT REPORT AS THE LOCKING BAR IS DISASSOCIATED FROM THE TRAY. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE LATERAL BEARING, MEDIAL BEARING, AND LOCKING BAR DETERMINED THAT THESE PARTS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL COMPLAINTS THAT WERE INVESTIGATED, AND IT WAS DETERMINED THAT NO FURTHER ACTION IS REQUIRED DUE TO TIME FRAME OVER WHICH THE PRODUCTS WERE MANUFACTURED. THE MOST LIKELY ROOT CAUSE OF THIS EVENT IS THAT THE LOCKING BAR WAS NOT FULLY SEATED AT THE TIME OF IMPLANTATION DUE TO THE LACK OF WEAR AND OTHER MARKINGS ON THE LOCKING BAR CLIP. HOWEVER, AS IT IS STATED IN THE COMPLAINT REPORT THAT AN AUDIBLE CLICK WAS HEARD AND THE SURGICAL TECHNIQUE WAS FOLLOWED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED STATES THAT BONE FRAGMENTS GENERATED DURING SURGERY, SMALL PARTICLES OF CEMENT AND SOFT TISSUES WERE OBSERVED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE APPROXIMATELY SEVEN WEEKS POST IMPLANTATION DUE TO THE LOCKING BAR BACKING OUT, WHICH ALSO CAUSED THE PATIENT PAIN. THE LOCKING BAR AND TIBIAL BEARINGS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789968 VANGUARD COMPLETE KNEE SYSTEM XP-XP TIBIAL TRAY 67MM ¿ INTERLOK LOCKING BAR & CE PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS N/A 162930

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R