BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GNS II RESURF PAT 32MM

    MDR report key: 8348557 · Received February 18, 2019

    Report

    Report Number
    1020279-2019-00652
    Event Type
    Injury
    Date Received
    February 18, 2019
    Date of Event
    September 22, 2017
    Report Date
    June 16, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    03596010208309
    PMA / PMN Number
    K951987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF COMPLAINT HISTORY DID NOT REVEAL ADDITIONAL COMPLAINTS FOR THE LISTED BATCHES. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. WITHOUT THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION CANNOT PROCEED. IF THE DEVICES OR NEW INFORMATION IS RECEIVED IN THE FUTURE, THESE COMPLAINTS CAN BE RE OPENED. THE CLINICAL MEDICAL INVESTIGATION CONCLUDED THAT, ALTHOUGH IT WAS REPORTED THAT THE PATIENT HAD A KNEE ARTHROSCOPY PERFORMED ON TWO DIFFERENT OCCASIONS, NO PROCEDURE DOCUMENTATION HAS BEEN PROVIDED FOR REVIEW. IT WAS ALSO REPORTED THAT THE PATIENT RECEIVED SEVERAL ASPIRATIONS AND WITHOUT THE RESULTS OF THE KNEE ASPIRATIONS WE ARE UNABLE TO RULE OUT AN INFECTION AS A CONTRIBUTORY FACTOR OR THE SUTURES, WHICH WERE REMOVED IN THE SECOND PROCEDURE. THE PATIENT IMPACT BEYOND THE PROCEDURES CANNOT BE DETERMINED.MIMB REVIEW. ASSESS SEVERITY OF COMPLAINT CASE TO DETERMINE IF ADDITIONAL ACTIONS OR INPUTS ARE REQUIRED FOR INCLUSION IN THE MEDICAL ASSESSMENT. DETERMINE IF A MEDICAL ASSESSMENT WILL BE PERFORMED BASED ON A REVIEW OF THE COMPLAINT DETAILS AND FURTHER INPUT FROM THE MEDICAL DIRECTOR/DESIGNEE.REVIEWED DURING MIMB. A MEDICAL INVESTIGATION WILL BE PERFORMED. PROCEED BASED ON INFORMATION PROVIDED OR AVAILABLE FOR THE INVESTIGATION; IF NO RELEVANT CLINICAL INFORMATION IS PROVIDED, RECOMMEND CLOSURE. APPROVED BY DR. LUCA ORLANDINI AND/OR J. TEMPLETON, MEDICAL DIRECTOR.A REVIEW OF RELEVANT CLINICAL/MEDICAL INFORMATION IN THE REPORTED ISSUE, INCLUSIVE OF TECHNIQUE AND PATIENT INFORMATION, TO INCLUDE, BUT NOT LIMITED TO: ¿PATIENT INFORMATION ¿SURGICAL PROCEDURE/POST-OPERATIVE CARE REVIEW ¿DEVICE LABELING (INCLUDING TECHNIQUE GUIDES, IFUS, ETC.)CONCLUSION:C-0231323, C-0232473, C-0232474: DETAILS REGARDING THE PATIENT¿S WEIGHT-BEARING STATUS, BONE QUALITY, AND OTHER ADDITIONAL CLINICAL RELEVANT INFORMATION HAVE NOT BEEN PROVIDED. BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE DEVICE FOR EVALUATION AND DIAGNOSTIC IMAGES, THE ROOT CAUSE OF THE REPORTED PAIN AND LOOSENING CANNOT BE DETERMINED. HOWEVER, THE ONGOING PAIN IS LIKELY DUE TO THE LOOSENING OF THE COMPONENT, AND BASED ON THE PATIENT MEDICAL RECORDS THE PATIENT SUSTAINED MULTIPLE FALLS IN INJURIES FOLLOWING HER IMPLANTATION, THESE INJURIES CANNOT BE RULED OUT AS CONTRIBUTING FACTORS FOR LOOSENING OF THE COMPONENTS. C-0232354, C-0232483, C-0232487, C-0232492 & C-0232355, C-0232517, C-0232521, C-0232532: ALTHOUGH IT WAS REPORTED THAT THE PATIENT HAD A KNEE ARTHROSCOPY WAS PERFORMED ON TWO DIFFERENT OCCASIONS NO PROCEDURE DOCUMENTATION HAS BEEN PROVIDED FOR REVIEW. IT WAS ALSO REPORTED THAT THE PATIENT RECEIVED SEVERAL ASPIRATIONS AND WITHOUT THE RESULTS OF THE KNEE ASPIRATIONS WE ARE UNABLE TO RULE OUT AN INFECTION AS A CONTRIBUTORY FACTOR OR THE SUTURES WHICH WERE REMOVED IN THE SECOND PROCEDURE. THE PATIENT IMPACT BEYOND THE PROCEDURES CANNOT BE DETERMINED. NO FURTHER CLINICAL ASSESSMENT IS WARRANTED AT THIS TIME. APPROVED BY JUSTIN TEMPLETON, MD 4/4/2019

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTHROSCOPY WAS PERFORMED DUE TO KNEE EFFUSION AND PAIN AN ADDITIONALLY AN ASPIRATION AND A CORTISONE INJECTION WERE GIVEN A MONTH AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140520 GNS II RESURF PAT 32MM PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY JWH SMITH & NEPHEW, INC. 16HM06284 03596010208309

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R