BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEN TIB PLY OLAY M LM/RL 8MM

    MDR report key: 7875133 · Received September 13, 2018

    Report

    Report Number
    1020279-2018-01810
    Event Type
    Injury
    Date Received
    September 13, 2018
    Date of Event
    July 10, 2018
    Report Date
    November 26, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HSX
    UDI-DI
    03596010501547
    PMA / PMN Number
    K912735
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED COMPLAINT DEVICE WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED GENESIS UNI TIBIA POLY ONLAY INDICATED THE PRESENCE OF CEMENT IN THE GROOVES. THERE WAS SURFACE DAMAGE ON THE DISTAL SIDE, INDICATING ATTEMPTED USE. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A DIMENSIONAL EVALUATION INDICATED THAT ONLAY INDICATED THAT IT WAS CORRECTLY SIZED. A REVIEW OF COMPLAINT HISTORY ON THE LISTED PARTS REVEALED NO PRIOR COMPLAINTS FOR THE LISTED BATCHES. A CLINICAL ANALYSIS INDICATED THAT BASED ON THE AVAILABLE INFORMATION AND THE DIMENSIONAL EVALUATION OF THE RETURNED PRODUCT, A ROOT CAUSE OF THE INSERT ¿NOT ADAPTING TO THE PATIENT¿ CANNOT BE CONCLUDED AS THE DIMENSIONAL ANALYSIS FOUND THE PRODUCT TO BE CORRECT WITH THE LABELING. NO CLINICAL/MEDICAL RECORDS OR X-RAYS WERE PROVIDED FOR THIS INVESTIGATION. NO INFORMATION ON THE PATIENT¿S CURRENT STATUS HAS BEEN PROVIDED. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE IMPLANT HAS BEEN CHECKED AT ITS REMOVAL FROM THE PACKAGING. IT WAS A MEDIUM IMPLANT OF 8 MM. IT HAS BEEN CEMENTED ON THE PATIENT BUT WAS NOT ADAPTED TO THE PATIENT. EXPLANTATION OF THE IMPLANT BECAUSE ITS SIZE WAS NOT MEDIUM COMPARED TO THE TRIAL IMPLANT BUT LARGE. USE OF A BACKUP IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713733 GEN TIB PLY OLAY M LM/RL 8MM PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER HSX SMITH & NEPHEW, INC. 15AM03521 03596010501547

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R