BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MJS ANATOMIC KNEE

    MDR report key: 6250374 · Received January 13, 2017

    Report

    Report Number
    1644408-2017-00006
    Event Type
    Injury
    Date Received
    January 13, 2017
    Date of Event
    December 19, 2016
    Report Date
    March 3, 2017
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    UDI-DI
    00888912121774
    PMA / PMN Number
    K922859
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS POLY INSERT WEAR. THE IMPLANT IN-VIVO SERVICE LENGTH IS NOT CONFIRMED WITHOUT AN ORIGINAL SURGERY DATE, HOWEVER; THE COMPLAINT DOES STATE THE IMPLANTS WERE IMPLANTED ABOUT 13 YEARS AGO. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, OR ACCIDENTS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR THIS REVISION SURGERY. THERE ARE NO REPORTED PRE-EXISTING PATIENT HEALTH CONDITIONS. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS NOT CONDUCTED SINCE A LOT NUMBER WAS NOT PROVIDED OR DETERMINED DURING THE COMPLAINT EVALUATION. A SEARCH OF THE DEVICE INVESTIGATION HISTORY PRODUCED NO ANOMALIES OR EVIDENCE OF A PRODUCT ISSUE. MULTIPLE SEARCHES OF THE DJO SURGICAL RECORDS AND PATIENT DATABASE REVEALED NO ADDITIONAL INFORMATION CONCERNING THIS EVENT. THIS COMPLAINT WILL BE CLOSED WITH THE LOT UNKNOWN PENDING RECEIPT OF ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE CONCERNING THIS COMPLAINT, THE COMPLAINT WILL BE RE-OPENED AND A FURTHER REVIEW SHALL BE CONDUCTED. THIS COMPLAINT IS DEEMED TO BE NON-PRODUCT RELATED. THE COMPLAINT STATES THE SURGEON MENTIONED THE POLY INSERT HAD WEAR AND THAT THE IMPLANTS WERE POSSIBLY IN-VIVO FOR 13 YEARS. THIS REVISION WAS NECESSARY TO CORRECT THE PATIENT'S CONDITION. THE ROOT CAUSE FOR THE WEAR WAS NOT REPORTED. NO OTHER CONDITIONS RELATING TO THIS EVENT COULD BE DETERMINED WITH CONFIDENCE. THE SURGEON REPORTED NO ISSUES ASSOCIATED WITH THE EXPLANTED PRODUCT. THE COMPLAINT INVESTIGATION IS LIMITED IN SCOPE SINCE THE PART (S) ASSOCIATED WITH THIS INVESTIGATION WAS NOT RETURNED TO DJO SURGICAL FOR EVALUATION. INVENTORY CONTAINMENT IS NOT REQUIRED SINCE THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT HAD A KNEE DONE 13 YEARS AGO. THE SURGEON REVISED THE INSERT AND MENTIONED THE INSERT HAD A LITTLE WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34137 MJS ANATOMIC KNEE INSERT,TIBIAL#5 MJS ANATOMIC 1 X-LG 10X76 JWH ENCORE MEDICAL, L.P. 00888912121774

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention 77-0001-5B