BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 2847081 · Received November 27, 2012

    Report

    Report Number
    2210968-2012-07672
    Event Type
    Injury
    Date Received
    November 27, 2012
    Report Date
    November 8, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-07673. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED A PATIENT HAD A LEFT TOTAL KNEE REPLACEMENT ON 09/20/2012 AND SUTURE WAS USED. THE PATIENT WAS SEEN THREE TO FOUR WEEKS POST OPERATIVE AND HAD SWELLING AND ITCHING ABOVE AND BELOW THE KNEE. THE PATIENT WAS SEEN AGAIN AT EIGHT WEEKS POST OPERATIVELY AND HAD LESS SWELLING BUT THE KNEE WAS DISCOLORED WITH PAPULOUS AREAS. THE PATIENT WAS TREATED WITH A TOPICAL STEROID, ULTRAVATE CREAM TWICE DAILY. ON (B)(6) 2012, 72 DAYS POST-OPERATIVELY, THE SKIN ERUPTIONS AND DEEPER DERMAL PAPULES AND NODULES HAD GOTTEN BETTER. THE DERMATOLOGIST OPINES THAT THE SUTURE CREATED AN ALLERGIC OR INFLAMMATORY RESPONSE BECAUSE THE INFLAMMATORY REACTION OCCURRED IN EXACTLY THE LOCATION OF WHERE THE SUTURE WAS PLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT HAD A LEFT TOTAL KNEE REPLACEMENT ON (B)(6) 2012 AND SUTURE WAS USED. THE PATIENT WAS SEEN THREE TO FOUR WEEKS POST OPERATIVE AND HAD SWELLING AND ITCHING ABOVE AND BELOW THE KNEE. THE PATIENT WAS SEEN AGAIN AT EIGHT WEEKS POST OPERATIVELY AND HAD LESS SWELLING BUT THE KNEE WAS DISCOLORED WITH PAPULOUS AREAS. THE PATIENT WAS TREATED WITH A TOPICAL STEROID CREAM . NOW AT 72 DAYS POST-OPERATIVE THE SKIN ERUPTIONS AND DEEPER DERMAL PAPULES AND NODULES HAVE GOTTEN BETTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention ZIMMER KNEE PROSTHESES