BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIDENTIFIED SIGMA UNI INSTRUMENT

    MDR report key: 3943459 · Received July 18, 2014

    Report

    Report Number
    1818910-2014-23736
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    May 9, 2014
    Report Date
    June 20, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT TOGETHER WITH FURTHER INFORMATION FROM THE DEPUY SALES REP WAS FORWARDED TO OUR BIO ENGINEERING DEPT FOR INVESTIGATION. A REPORT WAS RECEIVED FROM BIO ENGINEERING ((B)(4) BIO ENG REPORT) WHICH CONCLUDES: THE COMPLAINT OF ¿MR (B)(6) HAS HAD 2 TIBIAL FRACTURES WHILST USING PARTIAL INSTRUMENTS FOR A UNICOMPARTMENTAL KNEE WITH AN ALL POLY TIBIA¿ CANNOT BE CONFIRMED AS NO X-RAYS, IMAGES OR COMPLAINT SAMPLES WERE RETURNED. IN CONVERSATION WITH THE SALES REP IT IS BELIEVED THAT ALL THE CORRECT ALL-POLY INSTRUMENTS WERE USED IN THIS PROCEDURE AND THE CORRECT PROCEDURAL STEPS WERE FOLLOWED AS PER THE SURGICAL TECHNIQUE. A REVIEW OF THE INSTRUMENT AND IMPLANT DESIGNS INDICATES THAT A CEMENT MANTLE OF 1MM, AS PER THE SURGICAL TECHNIQUE IS OBTAINED AT NOMINAL CONDITION. IN SOME MANUFACTURING CONDITIONS A SLIGHT INTERFERENCE IS PERMITTED AT SOME REGIONS, HOWEVER, AS THERE HAS BEEN ONLY 1 OTHER COMPLAINT FOR 2INTRA-OPERATIVE TIBIAL FRACTURE NOTED WITHIN THE DEPUYSYNTHES COMPLAINT SYSTEM, THIS INTERFERENCE IS NOT BELIEVED TO BE CONTRIBUTING TO FRACTURE. A STUDY OF THE FRACTURE RATES OF KNEE ARTHROPLASTY PROCEDURES WITHIN THE NJR CONCLUDED THAT THERE WAS NO SIGNIFICANT STATISTICAL DIFFERENCE (ALPHA=0.05) BETWEEN SIGMA HP UNICONDYLAR (0.22%) AND THE BICONDYLAR LCS (0.15%) AND SIGMA KNEE PLATFORMS (0.14%). THIS INFORMATION INDICATES THAT THERE APPEARS TO BE NO DESIGN ISSUE WITH THE SIGMA HP UNI SYSTEM AS ONLY ONE COMPLAINT EXISTS WITHIN OUR INTERNAL SYSTEMS AND THE INCIDENCE OF INTRA-OPERATIVE FRACTURE IS STATISTICALLY COMPARABLE TO BICONDYLAR PLATFORMS. FROM THE LIMITED INFORMATION GATHERED IT IS DIFFICULT TO CONCLUDE ON THE ROOT CAUSE OF THE TIBIAL FRACTURE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, A NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. POST MARKET SURVEILLANCE IS PER SEP-419.

    Description of Event or Problem · 1

    SURGEON HAS HAD 2 TIBIAL FRACTURES WHILST USING PARTIAL INSTRUMENTS FOR A UNICOMPARTMENTAL KNEE WITH AN ALL POLY TIBIA. PATIENT AFFECTED AS PLATEAU FRACTURE NEEDED TO BE FIXED AND IS LIKELY NOT TO WEIGHT BEAR OR DISCHARGE AS QUICKLY AS EXPECTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423016 UNIDENTIFIED SIGMA UNI INSTRUMENT KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC.1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention