BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRISTEM PLASTIC SURGERY MATRIX XS

    MDR report key: 2844621 · Received November 16, 2012

    Report

    Report Number
    3005920706-2012-00010
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 22, 2012
    Manufacturer
    ACELL INC.
    Product Code
    FTM
    PMA / PMN Number
    K041140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACELL HAS SPOKEN TO SURGEON AND REVIEWED RELEVANT MEDICAL RECORDS. BASED ON ITS REVIEW, ACELL IS NOT AWARE OF ANY CLINICAL OF PATHOLOGICAL EVIDENCE INDICATING ITS PRODUCT WAS RELATED TO THE NEED FOR EXPLANT. THIS MDR IS BEING SUBMITTED OUT OF AN ABUNDANCE OF CAUTION. ON (B)(6) 2012, AFTER UNDERGOING "NUMEROUS OPERATIONS" AND MULTIPLE INFECTIONS PREVIOUSLY, PHYSICIAN SCHEDULES SURGERY IN ORDER TO "CONTROL INFECTION AND TRY TO SAVE HER LIFE". "POTENTIAL PROBLEMS HAVE BEEN DISCUSSED. SHE OPTED TO PROCEED, UNDERSTANDING THAT THIS IS A LIFESAVING MEASURE." SURGICAL INTERVENTION FOR INFECTED LEFT TOTAL HIP, PELVIC DISASSOCIATION, STATUS POST DEBRIDEMENT, BORDERLINE C PHYSIOLOGIC COAST HOST WITH OPEN DRAINING SINUS TRACTS, OSTEOMYELITIS OF PELVIS AND FEMUR. ACELL PSMX 150 SQ CM IMPLANTED ALONG WITH STIMULAN HEADS AND ANTIBIOTIC MIXTURE. ON (B)(6) 2012, PT PRESENTS WITH LARGE INFARCT AND DRAINAGE OF MILKY SUBSTANCE. "SHE HAS A LOT OF VASCULAR ISSUES ASSOCIATED WITH THE PRIOR FLAP FROM THE HEMIPELVECTOMY BECAUSE OF PROBLEMS WITH THE INTERIOR VESSELS AND SCARRING. THE POTENTIAL PROBLEMS ARE THE SAME AND INCLUDE INFECTION, WOUND HEALING AND NEED FOR FURTHER SURGERY. WE WILL SET UP AN ADMISSION FOR SUNDAY THROUGH INTERNAL MEDICINE." ON (B)(6) 2012, SURGICAL INTERVENTION PERFORMED WITH OPEN INCISIONAL BIOPSY, RADICAL DEBRIDEMENT AND ANTIBIOTICS. ON (B)(6) 2012, OPEN INCISIONAL SURGERY. "THE WOUND APPEARED MUCH BETTER THAN IT LOOKED LAST TIME."

    Description of Event or Problem · 1

    ACELL PRODUCT WAS IMPLANTED INTO PT ON (B)(6) 2012. THIS PRODUCT WAS LATER EXPLANTED DURING A PROCEDURE ON (B)(6) 2012. PATHOLOGY (B)(6) 2012. MIXED INFLAMMATION INVOLVING HIP JOINT WITH ADJACENT FIBROSIS, FAT NECROSIS, AND SKELETAL MUSCLE ATROPHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRISTEM PLASTIC SURGERY MATRIX XS FTM, SURGICAL MESH FTM ACELL INC. SM2178-60

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R 40 ML OF STIMULAN| 240 MG OF TOBRAMYCIN| STIMULAN BEADS| 500 MG OF VANCOMYCIN PER 10 ML MIXTURE