BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA C/S STTB IN20MM/SZ 4

    MDR report key: 3212871 · Received July 9, 2013

    Report

    Report Number
    1818910-2013-20727
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    July 4, 2013
    Report Date
    July 4, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC
    Product Code
    JWH
    PMA / PMN Number
    PK961685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PROVIDED PRODUCT/LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. TWO X-RAY IMAGES WERE PROVIDED: ONE A/P VIEW AND ONE M/L VIEW. BOTH IMAGES ARE VERY POOR, WITH BRIGHT SPOTS INDICATING CAMERA FLASH ON THE IMAGES. NO DATES ARE PRINTED ON THE IMAGES, SO X-RAY DATES CANNOT BE CONFIRMED. THREE PHOTOGRAPHS OF THE EXPLANTS WERE PROVIDED: ONE EACH OF THE FEMORAL COMPONENT, POLY INSERT, AND TIBIAL BASE. PHOTOGRAPH OF FEMUR AND TIBIAL BASE DO NOT INDICATE ABNORMAL WEAR OR DAMAGE, BUT EXPLANTS WERE NOT AVAILABLE FOR PHYSICAL EXAMINATION. PHOTOGRAPH OF POLY INSERT INDICATES A BROKEN SPINE. IT IS DIFFICULT TO DETERMINE POLY WEAR FROM THE PHOTO WITHOUT REVIEWING THE EXPLANT. THE COMPLAINT NOTES SHOW THAT THE SURGEON REPORTED THAT THE PATIENT HAD HAD A NUMBER OF FALLS DURING THE 10 YEARS THAT THE IMPLANT HAD BEEN IN SITU. THE CAUSE OF THE POLY INSERT SPINE BREAKAGE CANNOT BE DEFINITIVELY DETERMINED WITH THE INFORMATION PROVIDED. THE PATIENT IS OF UNKNOWN GENDER WITH A CALCULATED BMI OF (B)(6). THE PATIENT IS CONSIDERED OBESE. IT IS STATED IN THE WARNINGS AND PRECAUTIONS THAT EXCESSIVE PATIENT WEIGHT TEND TO ADVERSELY AFFECT KNEE REPLACEMENT IMPLANTS. THE INVESTIGATION CAN DRAW NO FURTHER CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    REVISION WAS CONDUCTED DUE TO INSTABILITY DURING SURGERY WAS IT WAS DISCOVERED THAT THE POST ON THE INSERT HAD BEEN BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314343 PFC*SIGMA C/S STTB IN20MM/SZ 4 TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC 49980A

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention