(b)(4).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.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.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon products (pds ii suture) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products (pds ii suture) used in this procedure? citation: the orthopedic journal of sports medicine; 4(6).2325967116654114.Doi: 10.1177/2325967116654114.[(b)(4)].
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It was reported via a journal article"title: comparison of time to recurrence of instability after open and arthroscopic bankart repair techniques authors: mandeep s.Virk, md; richard l.Manzo, md; mark cote, dpt; james k.Ware, md; augustus d.Mazzocca, md; carl w.Nissen, md; kevin p.Shea, md; robert a.Arciero, md citation: the orthopedic journal of sports medicine; 4(6).2325967116654114.Doi: 10.1177/2325967116654114.The purpose of the study was to compare the time to recurrence (ttr) of instability and disease-specific outcome measures in patients undergoing open and arthroscopic bankart repair.Patients with recurrent traumatic anterior shoulder instability and a bankart lesion on diagnostic arthroscopy underwent either open bankart repair (ob; 24 patients; age range: 20.3 to 27.5 years; 1 female and 23 male patients) or arthroscopic bankart and suture capsulorrhaphy (absc; 58 patients; age range: 22.3 to 27.2 years; 13 female and 45 male patients) using suture anchors.During the surgical procedure in the arthroscopic technique, after elevating the scarred labrum and preparing the glenoid rim to reveal bleeding subchondral bone, pds 0 sutures (ethicon) was used to place the shuttling suture through the labrum with the use of the spectrum suture passer.The first passing suture was brought through the redundant capsule in a location inferior to the first intended anchor location (usually at 6 o'clock).The rotator interval was closed with a pds 0 sutures (ethicon).In the arthroscopic technique group, reported complications included patient 3, an (b)(6) patient with subluxation; patient 4, a (b)(6) patient with dislocation; patient 5, a (b)(6) patient with subluxation; patient 7, a (b)(6) patient with subluxation; patient 8, a (b)(6) patient with subluxation; patient 9, a (b)(6) patient with subluxation; patient 11, a (b)(6) patient with dislocation.It was reported that 4 of the 7 failures underwent revision surgery and 3 patients with recurrent subluxation refused surgery.This retrospective study demonstrates that the time of recurrence of instability is significantly shorter with arthroscopic bankart repair compared -with the open bankart repeur technique.However, the recurrence of instability (dislocation and symptomatic subluxation) and instability-specific outcome measures (wosi scores) were not significantly different between the open and arthroscopic bankart repair techniques.
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