MERSILENE TAPE UNKNOWN PRODUCT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2018-11-27 for MERSILENE TAPE UNKNOWN PRODUCT manufactured by Ethicon Inc..

Event Text Entries

[128575528] (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).
Patient Sequence No: 1, Text Type: N, H10


[128575529] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2210968-2018-77349
MDR Report Key8107273
Report SourceFOREIGN,LITERATURE
Date Received2018-11-27
Date of Report2018-11-08
Date Mfgr Received2018-11-08
Date Added to Maude2018-11-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDARLENE KYLE
Manufacturer StreetP.O. BOX 151, ROUTE 22 WEST
Manufacturer CitySOMERVILLE NJ 088760151
Manufacturer CountryUS
Manufacturer Postal088760151
Manufacturer Phone9082182792
Manufacturer G1ETHICON INC.
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMERSILENE TAPE UNKNOWN PRODUCT
Generic NameINSTRUMENT, SURGICAL, DISPOSABLE
Product CodeKDC
Date Received2018-11-27
Catalog NumberUNK
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerETHICON INC.
Manufacturer AddressP.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 088760151 US 088760151


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-11-27

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