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 Muscular Rigidity (1968); Pain (1994); Swelling/ Edema (4577)

Event Date 04/22/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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? 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).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: https://doi.Org/10.1016/j.Arthro.2020.04.034.

Event Description

Title: return to sport and patient satisfaction after meniscal allograft transplantation this study aimed to investigate patient return to sport and satisfaction after meniscal allograft transplantation (mat).Patients undergoing mat using a bone bridge technique between 2013 and 2015 were included.Of 117 patients, 87 (74.4%) were available at an average follow-up of 3.64 years (range, 2.01-5.13 years).The cohort was nearly evenly split between men (n ¼ 43, 49.4%) and women (n ¼ 44, 50.6%).The mean age at the time of surgery was 28.99 8.26 years, with a mean body mass index (bmi) of 25.49 4.04.A no.0 pds suture (ethicon, somerville, nj) was placed as a vertical mattress at the junction of the posterior and middle thirds of the meniscus to serve as a traction suture during placement into the knee.During placement, the arthroscope was placed in the ipsilateral portal and the meniscal repair cannula was placed in the contralateral portal.A suture-passing needle placed through the meniscal repair cannula was used to pass the pds suture through the appropriate accessory incision.While gentle traction was being applied to the pds suture, the meniscal allograft was advanced through the transpatellar tendon incision and into the operative compartment.The bone bridge was placed in the bone slot, and the knee was cycled through flexion and extension to ensure it was centered under the femoral condyle.The bone bridge was then secured using a 4.75 or 5.5-mm swivelock anchor (arthrex, naples, fl) anteriorly while gentle downward pressure was applied to the posterior bone block.Finally, the meniscus was secured to the joint capsule using an inside-out technique using 10 vertical mattress repair sutures advanced through a meniscal repair cannula.A total of 75 patients (86.2%) reported experiencing at least one symptom in their knee, with 43 (49.4%) reporting stiffness, 30 (34.5%) reporting swelling, 29 (33.3%) reporting catching or locking, 25 (28.7%) reporting frequent pain, 25 (28.7%) reporting occasional pain, and 15 (17.2%) reporting a feeling of giving out.Reoperation was performed in 26 patients (29.9%); failure occurred in 12 patients (13.8%; total knee arthroplasty in 1, unicompartmental arthroplasty in 2, and total meniscectomy in 9).Overall, 77.0% of patients were satisfied with their outcome.Prior to mat, 82 patients (94.3%) participated in sporting activities; 62 patients (75.6%) returned to at least one sport at 12.58 6.20 months postoperatively, with 30 (48.4%) reaching their preoperative level of intensity and 72 (87.8%) discontinuing at least one of their preoperative sports.The most common reasons for sports discontinuation postoperatively were prevention of further damage (73.6%), pain with activity (51.4%), fear of further injury (48.6%), surgeon recommendation (33.3%), and swelling with activity (30.6%).Patients were satisfied with their sports participation at a rate of 62.1%.Reported complications included n=75 experiencing at least one symptom in their knee, n= 43 reporting stiffness, n=30 swelling, n=29 reporting catching or locking, n=25 frequent pain, n=25 occasional pain, n=15 reporting a feeling of giving out, n=26 reoperation and n=12 failure occured.In conclusion, in a complex patient population undergoing arthroscopic mat, 75.6% of patients were able to return to at least one sport at an average of 12.58 6.20 months postoperatively.The level of sport declined, with 93.5% of patients restricting involvement to recreational sports after mat and 48.4% returning to their preoperative level of activity intensity.In addition, 87.8% of patients reported discontinuing a sport in which they had participated preoperatively.The most common reasons for decreasing level of sport were prevention of further damage, pain or swelling with sports, and fear of further injury.The reoperation rate after mat was 29.9%.Most patients were satisfied with the outcome of surgery, with 77.0% satisfied in general and 62.1% satisfied with their ability to play sports.

• 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
• MDR Report Key: 12722649
• MDR Text Key: 284464860
• Report Number: 2210968-2021-10603
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial
• Report Date: 10/13/2021

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: 10/13/2021
• Initial Date FDA Received: 10/29/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention