MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Fever (1858); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Skin Inflammation/ Irritation (4545); Insufficient Information (4580)

Event Date 08/26/2021

Event Type  Injury  

Event Description

Title: pyoderma gangrenosum after bilateral total knee arthroplasty.The aim of this case report was to discuss a case of a man with postoperative pg after bilateral total knee arthroplasty.A 62-year-old male patient with a past medical history of hypertension, hyperlipidemia, and paroxysmal atrial fibrillation presented to their orthopedic center for joint replacement with long-standing bilateral knee osteoarthritis.In addition, he has class 1 obesity, with a body mass index of 32 (kg/m2), and has worked as a high-technology machinist in silicon valley noting years of discomfort limiting his walking ability.With severe medial compartment and patellofemoral osteoarthritis, he was interested in proceeding with bilateral total knee replacement.The patient underwent bilateral total knee arthroplasty through standard medial parapatellar arthrotomy using zimmer nexgen cruciate-retaining knee replacement prostheses (warsaw, in) without intraoperative complication.Anesthetic technique included spinal, intravenous sedation, and adductor canal block placed under ultrasound guidance.A cemented technique was used with patellar resurfacing, prophylactic cefazolin, iv tranexamic acid, sequential tourniquet inflation, and total operative time for bilateral knee replacements of approximately 3 hours.Arthrotomy closure was performed with 1-pds ethicon (somerville, nj) suture, the dermis with 2-0 pds suture, and the skin with 3-0 prolene suture.Initial bandages included steri-strips, nonadherent gauze, sterile 4 x 8 gauze sponge, and compression wrap.Reported complications include fever, left knee redness, increased white blood cell (wbc) count, left knee superficial dehiscence at its distal aspect, inflammatory markers were elevated with an erythrocyte sedimentation rate of 106 and c-reactive protein of 21.6, knee wounds progressively worsened at postoperative day 18 with areas of soft-tissue necrosis now involving the right knee, eventually diagnosed with pyoderma gangrenosum.In conclusion, postsurgical pg is a challenging problem in regard to diagnostic confirmation and because of the limited evidence behind definitive treatment.As pg mimics necrotizing fasciitis and other infectious etiologies, there is a strong recommendation for medical consultation from a dermatologic and/or rheumatology specialist for even a low suspicion.This may help avoid damaging tissue debridement and speed the time to treatment with high-dose corticosteroids, the latter of course counter to usual treatments for infection.Definitive treatment in regard to soft-tissue coverage should be assisted by a plastic surgeon with a consideration for use of local wound treatments and dermal substitute before advancing up the reconstructive ladder to rotational or free muscle flaps.

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? this report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.(b)(4).Related events captured via 2210968-2022-09237.Citation: arthroplasty today (2021); 11: 73-79.Https://doi.Org/10.1016/j.Artd.2021.07.003.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15754291
• MDR Text Key: 303260513
• Report Number: 2210968-2022-09238
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2022
• Initial Date FDA Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male