BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*PLUS MD SKIN STPLR

    MDR report key: 8469288 · Received April 1, 2019

    Report

    Report Number
    3005075853-2019-17694
    Event Type
    Injury
    Date Received
    April 1, 2019
    Date of Event
    January 1, 2018
    Report Date
    March 7, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDT
    UDI-DI
    10705036002642
    PMA / PMN Number
    K833357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED. ATTEMPTS ARE BEING 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. PLEASE CONFIRM THE SPECIFIC NUMBER OF PATIENTS THAT REPORTED PAIN. HOW WAS THE PAIN TREATED? DOES THE PHYSICIAN BELIEVE THAT THE SKIN STAPLER CAUSED OR CONTRIBUTED TO ANY OF THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: "CENTRAL SENSITIZATION IS A RISK FACTOR FOR WOUND COMPLICATIONS AFTER PRIMARY TOTAL KNEE ARTHROPLASTY," CITATION: KNEE SURGERY, SPORTS TRAUMATOLOGY, ARTHROSCOPY (2018) 26: 3419¿3428; HTTPS://DOI.ORG/10.1007/S00167-018-4914-6; PUBLISHED ONLINE: 24 MARCH 2018. THE OBJECTIVE OF THIS PROSPECTIVE OBSERVATIONAL STUDY WAS TO INVESTIGATE WHETHER CENTRAL SENSITIZATION WAS ASSOCIATED WITH INCREASED RATES OF WOUND COMPLICATION AFTER PRIMARY TKA. BETWEEN JANUARY AND JUNE 2016, A TOTAL OF 161 UNILATERAL TKAS WITH POSTERIOR-STABILIZED (PS) PROSTHESIS WERE PERFORMED FOR THE TREATMENT OF END-STAGE KNEE OA. GROUP 1 CONSISTED OF 112 PATIENTS WITH MEAN AGE OF 71.4 YEARS (MALE N=16 AND FEMALE N=96) WITH A CENTRAL SENSITIZATION INVENTORY SCORE (CSI SCORE) LESS THAN 40 POINTS. GROUP 2 CONSISTED OF 49 PATIENTS WITH MEAN AGE OF 70.7 YEARS (MALE N=6 AND FEMALE N=43) WITH A CSI SCORE OF 40 POINTS OR MORE. THE DRAINAGE TUBE WAS PLACED IN THE JOINT BEFORE CLOSING THE JOINT CAPSULE USING A CONTINUOUS SUTURE WITH NO. 1 POLYGLACTIN 910 (COATED VICRYL PLUS, ETHICON INC., SOMERVILLE, NJ, USA) IN 45° OF KNEE FLEXION POSITION. FOR SUBCUTANEOUS APPROXIMATION SUTURE, NO. 2 POLYGLACTIN 910 (COATED VICRYL PLUS, ETHICON INC., SOMERVILLE, NJ, USA) WAS USED WITH BURIED KNOTS. SKIN WAS CLOSED USING A STAPLE GUN (PROXIMATE PLUS MD 35 W, ETHICON ENDO-SURGERY LLC, GUAYNABO, PUERTO RICO). IN GROUP 1, COMPLICATIONS INCLUDED PAIN POSTOPERATIVE 1 WEEK (MEAN OF 4.9), POSTOPERATIVE 6 WEEKS, (MEAN OF 3.1) AND POSTOPERATIVE 3 MONTHS (MEAN OF 1.5), WOUND DEHISCENCE N=1 AND PROLONGED WOUND OOZING N=2. IN GROUP 2, COMPLICATIONS INCLUDED WOUND DEHISCENCE N=6, PROLONGED WOUND OOZING N=5, HEMATOMA N=2 AND SUPERFICIAL SURGICAL SITE INFECTION N=1 AND PAIN POSTOPERATIVE 1 WEEK (MEAN OF 5.4), POSTOPERATIVE 6 WEEKS, (MEAN OF 4.0) AND POSTOPERATIVE 3 MONTHS (MEAN OF 2.4). PROLONGED WOUND OOZING REQUIRED SUTURING. HEMATOMA ASPIRATION WAS PERFORMED FOR HEMATOMA AND ANTIBIOTICS WERE PRESCRIBED FOR SUPERFICIAL SURGICAL SITE INFECTION. IN CONCLUSION, ALTHOUGH ALL WOUND COMPLICATIONS WERE TREATED WITH ADDITIONAL LOCAL WOUND CARE WITHOUT FURTHER OPERATION, CENTRAL SENSITIZATION IS A RISK FACTOR FOR THE DEVELOPMENT OF POSTOPERATIVE WOUND COMPLICATION AFTER PRIMARY TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263227 PROXIMATE*PLUS MD SKIN STPLR REMOVABLE (SKIN) GDT ETHICON ENDO-SURGERY, LLC. 10705036002642

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention