BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*SKIN STPLR (EXACT CODE UNKNOWN)

    MDR report key: 7352362 · Received March 20, 2018

    Report

    Report Number
    3005075853-2018-08622
    Event Type
    Injury
    Date Received
    March 20, 2018
    Report Date
    February 27, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDT
    PMA / PMN Number
    K833357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 3/28/2018. CORRECTED DATA: MDR DECISION: NOT REPORTABLE. UPON REVIEW OF THE INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT AND IS BEING CONSIDERED NOT REPORTABLE. ADDITIONAL INFORMATION OBTAINED: PER THE AUTHOR, THE COMPLICATIONS MENTIONED IN THE ARTICLE WERE NOT RELATED TO ETHICON DEVICES.

    Additional Manufacturer Narrative · 1

    (B)(4) BATCH # UNK THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. ATTEMPTS WERE MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: A PROSPECTIVE RANDOMISED COMPARISON OF 2 SKIN CLOSURE TECHNIQUES IN PRIMARY TOTAL HIP ARTHROPLASTY SURGERY. AUTHOR(S): RUI M, ZHENG X, SUN SS, LI CY, ZHANG XC, GUO KJ, ZHAO FC, PANG Y CITATION: HIP INT. 2017 NOV 13:0. DOI: 10.5301/HIPINT.5000534. THE PURPOSE OF THIS PROSPECTIVE RANDOMISED CLINICAL STUDY WAS TO COMPARE THE CLINICAL OUTCOMES AND COSTS BETWEEN STAPLES AND SUBCUTICULAR SUTURE TECHNIQUES. FROM MAR2014 TO JUN2014, 165 PATIENTS WHO UNDERWENT PRIMARY UNILATERAL THA THROUGH A POSTEROLATERAL APPROACH WERE RANDOMIZED INTO TWO SKIN CLOSURE TECHNIQUES: STAPLER GROUP (N=83; N=36 MALE, N=47 FEMALE; MEAN AGE 55.7 YEARS) AND SUTURE GROUP (N=82; N=39 MALE, N=43 FEMALE; MEAN AGE 57.8 YEARS). IN SUTURE GROUP, SUPERFICIAL SKIN CLOSURE WERE CLOSED WITH A RUNNING SUBTICULAR 4-0 VICRYL SUTURES. IN STAPLER GROUP, WOUNDS WERE CLOSED WITH METALLIC SKIN STAPLES (JOHNSON AND JOHNSON INC.). IN STAPLER GROUP, 2 PATIENTS ((B)(6) FEMALE AND (B)(6) MALE) EXPERIENCED SUPERFICIAL SURGICAL SITE INFECTIONS. THE PATIENT WERE TREATED WITH INTRAVENOUS CEFUROXIME (1.5 G/DAY) AND A 75% ALCOHOL SOAKED DRESSING WAS UTILIZED AND CHANGED PER DAY. CLOSURE WITH RUNNING SUBCUTICULAR SUTURE IS CHEAPER AND APPEARS TO HAVE A CLINICAL ADVANTAGE WHEN COMPARED WITH METALLIC STAPLES SKIN CLOSURE IN PRIMARY THA SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198934 PROXIMATE*SKIN STPLR (EXACT CODE UNKNOWN) REMOVABLE (SKIN) GDT ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention