BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY IMPRINT POSTERIOR STABILIZING KRS

    MDR report key: 19937411 · Received August 8, 2024

    Report

    Report Number
    3004153240-2024-00015
    Event Type
    Injury
    Date Received
    August 8, 2024
    Date of Event
    July 1, 2024
    Report Date
    May 18, 2026
    Manufacturer
    CONFORMIS
    Product Code
    JWH
    UDI-DI
    M572TPS000D002011
    PMA / PMN Number
    K231233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TWO (BILATERAL) IDENTITY IMPRINT PS KNEE IMPLANT SYSTEMS WERE ORDERED FOR THE PATIENT VIA ELECTRONIC SUBMISSION OF IMPLANT REQUESTS FORMS ("IRF") ON (B)(6) 2024. SERIAL NUMBER ("SN") (B)(6) WAS ASSIGNED TO THE ORDER FOR THE RIGHT KNEE SYSTEM AND SN (B)(6) FOR THE LEFT. AS INDICATED ON THE IRFS THEMSELVES, BOTH ORDERS WERE ENTERED BY THE OFFICE SCHEDULER D.O.. PER THE IRFS, A SURGERY DATE OF (B)(6) 2024 WAS SPECIFIED BY THE ORDER PLACED FOR THE RIGHT KNEE SN: (B)(6) AND A SURGERY DATE OF(B)(6) 2024 WAS SPECIFIED BY THE ORDER PLACED FOR THE LEFT KNEE (B)(6). THE LEFT KNEE (B)(6) WAS MANUFACTURED AND SHIPPED ON 6/21/2024. PER THE FEDX RECORD SHOWING TRACKING: (B)(4) - THE IMPLANT SHIPPED TO THE SALES REPRESENTATIVE AND WAS HAND DELIVERED TO HOSPITAL. THE LEFT KNEE (B)(6) ARRIVED AT THE FACILITY ON THURSDAY (B)(6) 2024, WHICH WAS 3 DAYS PRIOR TO THE CASE SINCE THIS SURGERY WAS SCHEDULED FOR (B)(6) 2024. AS REFLECTED IN THE COPIES OF THE LABELS FOR THIS CASE INCLUDED IN THE DHR, THE LATERALITY OF THE DELIVERED KNEE SYSTEM WAS CLEARLY MARKED AS "LEFT" DIRECTLY AFTER THE PRODUCT NAME ON THE OUTER BOX LABEL, WHICH IS PLAINLY VISIBLE ON THE PRODUCT AS DELIVERED. AS OF 7/1/2024, THE RIGHT KNEE (B)(6) HAD NOT YET BEEN SHIPPED OR DELIVERED, AS THE SURGERY WAS SCHEDULED FOR (B)(6) 2024 ACCORDING TO THE IRF ENTERED BY THE SCHEDULER. RESTOR3D DID NOT RECEIVE ANY COMMUNICATION PRIOR TO 7/1/2024 RELATED TO MOVING THE SURGERY DATE FOR THE RIGHT KNEE (B)(6) EARLIER THAN (B)(6) 2024. THE SALES REPRESENTATIVE FOR THIS CASE, (B)(4) (THE "REP"), WAS CONTACTED BY TELEPHONE ON JULY 16, 2024, FOR AN ACCOUNT OF THE SURGERY ON (B)(6) 2024. ACCORDING TO THE REP, THE IMPLANTS WERE BROUGHT INTO THE O/R BY THE HOSPITAL TEAM. ACCORDING TO THE HOSPITAL TEAM'S STANDARD PROCEDURE, A TIME-OUT WOULD HAVE NEXT BEEN PERFORMED BEFORE SURGERY TO VERIFY THE CORRECT PATIENT AND PROCEDURE. THE REP, HOWEVER, WAS NOT PRESENT DURING THE TIME-OUT IN THE O/R IN THIS CASE BECAUSE PRIOR TO THE TIME-OUT, IT HAD BEEN DETERMINED THAT A DRILL NECESSARY FOR THIS CASE WAS NOT AVAILABLE IN THE O/R, AND THE REP WAS TASKED WITH LOCATING A DRILL IN A DIFFERENT AREA OF THE FACILITY DURING THE TIME-OUT. PER THE REP, THE SURGERY WAS DELAYED FROM 7:30AM TO 9:30AM DUE TO THE DELAY IN HAVING TO LOCATE THE MISSING DRILL. ACCORDING TO THE REP, DURING THIS DELAY, THE REP ALSO REVIEWED THE IVIEW DOCUMENT THAT ILLUSTRATES THE PATIENT-SPECIFIC SURGICAL PLAN FOR THE LEFT KNEE (B)(6) WITH THE SURGEON PRIOR TO THE CASE. THE REP ALSO REPORTED THAT THE IVIEW DOCUMENT WAS POSTED IN THE O/R AND CLEARLY VISIBLE TO ALL. AS CONFIRMED BY THE ATTACHED COPY OF THE IVIEW FOR LEFT KNEE (B)(6), THE LATERALITY FOR THE CASE IS CLEARLY SPECIFIED AS "LEFT" IN RED LETTERING IN THE TOP RIGHT OF EACH PAGE OF THE DOCUMENT. ACCORDING TO THE REP, THE SURGEON BEGAN THE PROCEDURE AND HAD CLEANED OUT THE RIGHT KNEE WHEN HE REALIZED THAT THE IMPLANT LATERALITY WAS A LEFT. THE SURGEON CLOSED THE INCISION ON THE RIGHT KNEE AND PLACED THE PATIENT IN A BRACE UNTIL THE RIGHT KNEE WAS AVAILABLE. RESTOR3D WAS FIRST NOTIFIED VIA EMAIL BY OUR RESTOR3D REPRESENTATIVE (B)(4) ON 7/1/2024 OF A REQUEST FROM THE PROVIDER TO MOVE THE SURGERY DATE FOR THE RIGHT KNEE (B)(6) EARLIER THAN (B)(6) 2024. RESTOR3D WAS ABLE TO MOVE THE SURGERY DATE FOR THE RIGHT KNEE (B)(6) TO (B)(6) 2024 AND IT WAS SHIPPED ON 7/3/2024. THE SURGERY TOOK PLACE ON (B)(6) 2024 FOR THE RIGHT KNEE SN:(B)(6). THE LEFT KNEE SN: (B)(6) IS CURRENTLY NOT SCHEDULED. THE INCIDENT OCCURRED DUE TO INACCURATE (EITHER INCORRECT FROM THE BEGINNING OR NOT UPDATED UPON SUBSEQUENT CHANGE OF PLANS BY PATIENT/SURGEON) SURGERY DATES SUBMITTED BY THE FACILITY, COMPOUNDED BY THE FACT THAT NO ONE AT THE FACILITY THAT WAS AWARE OF THE INTENT TO PERFORM A RIGHT KNEE REPLACEMENT ON (B)(6) 2024 NOTED THAT THE RESTOR3D KNEE REPLACEMENT SYSTEM THAT WAS DELIVERED ON (B)(6) 2024 WAS A SYSTEM. DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE FAILURE MODE.

    Description of Event or Problem · 0

    THE SURGERY DATE WAS REFLECTED ON THE ORIGINAL ORDER STATUS AS (B)(6) 2024, SN (B)(6) (LEFT) AND SN (B)(6) (RIGHT). ONE IMPLANT FOR THIS PATIENT WAS DELIVERED TO (B)(6) MEDICAL CENTER ON (B)(6) 2024. PRIOR TO SURGERY, THE PATIENT REQUESTED THAT THE RIGHT KNEE BE REPLACED. ON (B)(6) 2024, IN THE OPERATING ROOM, THE MEDICAL DEVICE REPRESENTATIVE OPENED THE PACKAGE AND HANDED THE PEEL-PACKED IMPLANT TO THE CIRCULATOR. ONCE THE IMPLANT IS OUT OF THE PACKAGE, THERE IS NO IDENTIFICATION ON THE PEEL PACK AS TO LATERALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509943 IDENTITY IMPRINT POSTERIOR STABILIZING KRS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH CONFORMIS TPS-000-D002-010101 M572TPS000D002011

    Patients

    Seq Age Sex Outcome Treatment
    1