MAUDE Adverse Event Report: ETHICON INC. MERSILENE TAPE UNKNOWN PRODUCT; INSTRUMENT, SURGICAL, DISPOSABLE

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

Patient Problems Skin Irritation (2076); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(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 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 used in this procedure? citation: arthroscopy: the journal of arthroscopic and related surgery, vol 30, no 7 (july), 2014: pp 823-832; doi: http://dx.Doi.Org/10.1016/j.Arthro.2014.02.041.Note: adverse event related to (b)(6) patient reported via 2210968-2018-77347 and 2210968-2018-77348.(b)(4).

Event Description

It was reported via journal article: title: "clinical results of hamstring autografts in anterior cruciate ligament reconstruction: a comparison of femoral knot/press-fit fixation and interference screw fixation," author(s): wei-pin ho, m.D., chian-her lee, m.D., chang-hung huang, ph.D., chih-hwa chen, m.D., and tai-yuan chuang, m.D.Citation: arthroscopy: the journal of arthroscopic and related surgery, vol 30, no 7 (july), 2014: pp 823-832; doi: http://dx.Doi.Org/10.1016/j.Arthro.2014.02.041.This non-randomized retrospective study aimed to compare the clinical outcomes of femoral knot/press-fit anterior cruciate ligament (acl) reconstruction with conventional techniques using femoral interference screws.Between 199 and 2010, 73 patients completed the follow-up study and were allocated into two groups for arthroscopic acl reconstruction: group a (n=40; n=18 male and n=22 female; mean age of 32 [ranged 18-46 years]) using femoral knot/press-fit fixation; and group b (n=33; n=16 male and n=17 female; mean age of 34 [ranged 19-44 years]) using femoral interference screw fixation.In graft preparation, no.2 ethibond sutures was used to suture the knot in group a, and were used to affixed to the end of the tendon in group b.The mersilene tapes on the 2 grafts were secured to the prepositioned no.5 ethibond and drawn through the lateral aspect of the knee through the intercondylar notch and out the entrance of the tibial tunnel.Both treatment groups utilized mersilene tape in tibial fixation which was placed over a bone bridge for each tendon loop.At last follow-up, symptoms included pain during moderate or strenuous activities (n=2 group a; n=1 group b); swelling during moderate or strenuous activity (n=1 group b); symptoms of partial giving way during moderate or strenuous activities (n=1 group a); occasional full giving way during moderate or strenuous activities (n=1 group b); patella femoral crepitus with mild pain (n=1 group a; n=1 group b); and grade i osteoarthritis (n=7 group a; n=5 group b).Complications with femoral knot/press-fit method included skin irritation around mersilene tape tied at the tibial incision (n=4 group a; n=2 group b) for which one patient underwent removal of mersilene tape under local anesthesia 3 years after reconstruction.A (b)(6) female patient experienced frequent knee instability, knee pain and graft rupture.Femoral knot/press-fit acl reconstruction did not appear to provide increased anterior instability compared with that of conventional femoral interference screw acl reconstruction.

• Brand Name: MERSILENE TAPE UNKNOWN PRODUCT
• Type of Device: INSTRUMENT, SURGICAL, DISPOSABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8107273
• MDR Text Key: 128575528
• Report Number: 2210968-2018-77349
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention