MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE-TEX® CRUCIATE LIGAMENT; PROSTHESIS, LIGAMENT, PTFE

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Joint Swelling (2356)

Event Date 06/24/1994

Event Type  Injury  

Manufacturer Narrative

Information not provided.

Event Description

A voluntary medwatch was received by gore (mw5080790) which reported the following: wl gore soft tissue device for acl substitution, made of polytetrafluoroethylene.I rejected it.The distal aspect of this device disintegrated in vivo.Emergency room visit revealed "(b)(6)" colored fluid tapped from a grossly swollen joint and painful knee joint.Removal of this device was immediately scheduled.Over the years, i became increasingly ill.I am now disabled by illness and intractable pain.Hx: in the late 70s, resorbable screws were used as fixation devices during a routine acl repair.This was my first rejection of an artificial material.After having the wl gore device removed, i underwent an unsuccessful patellar graft, right to left.This failed due to the knee remaining reactive and otherwise problematic.The gore-tex device was placed in the late 80s, rejected in 1994.Ultimately my tkr (1997, johnson & johnson) has now become an object of issue.For the last 4 yrs, the affected joint has become more and more problematic.Currently ,the working diagnosis is that i am rejecting this medical device as well.The reports states implant date: (b)(6) 1989 and explant date: (b)(6) 1994.

Manufacturer Narrative

Voluntary medwatch attached.- attachment: [med watch mw5080790.Pdf].

• Brand Name: GORE-TEX® CRUCIATE LIGAMENT
• Type of Device: PROSTHESIS, LIGAMENT, PTFE
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8154649
• MDR Text Key: 130033462
• Report Number: 2017233-2018-00757
• Device Sequence Number: 1
• Product Code: LWA
• Combination Product (y/n): N
• PMA/PMN Number: P850074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/27/2018

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention