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(b)(4).This medwatch report is in response to receipt of maude event report mw5076056.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.If further details are received at the later date a supplemental medwatch will be sent.The patient demographic info: age, gender, weight, bmi at the time of the index procedure date and name of the index surgical procedure? the diagnosis and indication for the index surgical procedure? what was tissue location / placement of the suture? did the operating surgeon observe any suture deficiency or anomaly before, during after the suture placement? how long after the initial surgical procedure did the suture failure occur? did the suture break or did the suture pull out of the tissue? was there any precipitating stress factor for the suture breakage or pulling out of the tissue? was medical or surgical intervention performed? date? if reoperation was performed, please describe the appearance of the suture? other relevant patient history / concomitant medications? product code and lot number? will the product be returned? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status? you indicated this is ¿one of five such cases¿.Were the other 4 cases previously reported to ethicon? if not previously reported, for each case, please provide: 1.Patient demographic info: age, gender, weight, bmi at time of surgical procedure 2.Date and name of the index surgical procedure 3.How long after the initial surgical procedure did the suture failure occur? 4.Did the suture break or did the suture pull out of the tissue? 5.Was there any precipitating stress factor for the suture breakage or pulling out of the tissue? 6.Was medical or surgical intervention performed? date? 7.If reoperation was performed, please describe the appearance of the suture? 8.Product code and lot number? 9.What is the physician¿s opinion as to the etiology of or contributing factors to the event? 10.What is the patient¿s current status? - see [mw5076056 - (b)(4).Pdf].
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It was reported user facility medwatch that a patient underwent total knee arthroplasty on (b)(6) 2016 and barbed suture was used.Post operatively, the patient required reoperation on (b)(6) 2016 for failure of a single, unidirectional, symmetrically-barbed suture at the parapatellar arthrotomy repair site.The current condition of the patient is not known.Additional information has been requested.
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(b)(4).Date sent to the fda: 11/12/2018.This medwatch report is in response to receipt of maude event report mw5076056, reported via 2210968-2018-72641.Additional narrative: it was reported via journal article: ¿title: failure of a unidirectional barbed-suture device at the arthrotomy repair site following total and unicondylar knee arthroplasty¿; citation: jbjs case connect.2018; 8: e80 doi: http://dx.Doi.Org/10.2106/jbjs.Cc.18.00041 and patient 2 underwent a knee procedure on an unknown date and barbed suture was used.Following the index tka, patient 2 needed a polyethylene exchange, a synovectomy, and debridement of arthrofibrosis at the patella for flexion instability and patellar clunk syndrome.The unidirectional barbed suture failed 6 weeks subsequent to this revision procedure.The demographics and case histories of the 6 patients who needed reoperation are summarized in table ii.Of the 6 cases, 5 were tkas and involved dehiscence of the proximal portion of the vastus medialis and the proximal portion of a medial parapatellar arthrotomy, whereas 1 was a lateral uka and involved dehiscence of the vastus lateralis and the proximal portion of a lateral parapatellar arthrotomy.All of the patients had presented clinically with a palpable defect at the quadriceps tendon, and 4 tka cases had displayed increased lateral patellar tilt on the merchant view radiograph.All of the diagnoses had been confirmed with mri.Five of 6 patients were compliant with the prescribed treatment regimens after the index arthroplasty, including early range-of-motion exercises, adequate pain control with narcotic medication, and outpatient physical therapy.One patient was not fully compliant and continued range-of-motion exercises despite prescribed immobilization for wound drainage 1 week after surgery, although there was no specific injury.Although secondary immobilization and local wound care at 2 weeks postoperatively resulted in healing of the incision, it is possible that early arthrotomy failure was the cause of the wound drainage.However, the diagnosis was not made until 10 weeks postoperatively.Diagnosis of arthrotomy dehiscence occurred at a median of 6.5 weeks postoperatively (range, 5 to 20 weeks), resulting in reoperation at a median of 15.3 weeks (range, 8 to 37 weeks) after the index arthroplasty.Repairs were performed with interrupted nonabsorbable suture, which was oversewn with running barbed suture in 5 cases, and solely with interrupted nonabsorbable suture in a 2-layer arthrotomy closure in 1 case.Postoperatively, the knees were immobilized in extension for 2 weeks.At 2 weeks post-surgery, range of motion with gravity-assisted flexion was begun, and a progressive 6-week strengthening and range-of-motion protocol with physical therapy was followed.At a median of 14.4 weeks (range, 12 to 42 weeks) postsurgery, the outcome was good in all cases, as assessed by the lack of a palpable defect at the repair site, the ability to perform an active straight leg raise, 5 of 5 quadriceps strength, and lack of patient-reported pain.Merchant view radiographic follow-up was performed with 3 of 4 patients who had displayed increased patellar tilt, and all showed an improvement in angular tilt following the repair.The suture used in our patient relies on a fixation tab along with a perpendicular suture throw to obtain proximal fixation in the soft tissue.Because our failures occurred proximally, we hypothesize that there was failure of the fixation tab.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.Was any additional solution used in the wound? were there any precipitating events prior to failure diagnosis? adverse events related to patient 1 reported via 2210968-2018-77066.Prior knowledge of these patient events was established via user facility mw mw5076056: adverse events related to patient 3 reported via 2210968-2018-73360, user facility mw mw5076056.Adverse events related to patient 4 reported via 2210968-2018-73361, user facility mw mw5076056.Adverse events related to patient 5 reported via 2210968-2018-73364, user facility mw mw5076056.Adverse events related to patient 6 reported via 2210968-2018-73367, user facility mw mw5076056.
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