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| Device Problem
Insufficient Information (3190)
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| Patient Problem
Cancer (3262)
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| Event Date 11/22/2021 |
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Event Type
Injury
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Manufacturer Narrative
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No gore medical device has been associated with cancer.However, this event is being reported based only upon the unverified and unconfirmed information received.The exact date of event is unknown.Therefore, the date of which gore was made aware of the incident is used as date of event.Location of the device is unknown.Additional information has be requested, code 11 - gore is verifying and investigating the information received.
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Event Description
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It was reported to gore that a patient underwent an anterior cruciate ligament reconstruction in 1986 during which an alleged gore-tex ligament device was used.According to the reported information: ¿[the patient] has now been given a cancer diagnosis again which clinicians now believe is associated with the gore-tex graft that was originally implanted in 1986.¿ the information received further alleges: ¿[the patient] was classed as patient one in journals (the american journal of sports medicine published january 1998 volume 26) which documented the breakdown of his gore-tex 1 prosthetic graft, which was replaced by gore-tex cd in 1991.In september 1993, inguinal lymphadenopathy was identified in the patient's groin and was removed.The microbiologic and histologic examination showed a foreign body granulomatous reaction in the lymph node with evident gore-tex fragments.In june 2018 [the patient] received a diagnosis of cancer in his lacrimal gland near his eye and it had to be removed.This is a rare cancer and it was reported that the clinician at the time did not understand its origin.Now in 2021, [the patient] has been diagnosed with cancer in the same place as the previous lymph node his groin which gore tex and now also in the lymph node under his arm.¿.
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Manufacturer Narrative
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H6: updated investigation conclusions alleged implant: (b)(6) 1986.Labels: (b)(4).(b)(6) 1994: (b)(6).History sheet.Continuation notes.(b)(6).Clinical notes: (b)(6) 1994: seen on the ward round by mr.(b)(6).¿he had a goretex acl reconstruction twice to his right knee.The knee gives him constant pain which is not severe in intensity and he tells me he can do nearly everything with his right knee which includes playing football.On examination there is definitely some fluid in the right knee joint lines which is non-tender.Movements are from 0 to 95°.He definitely has some inguinal lymph node hypertrophy and tomorrow we will do an arthroscopy and take some synovial biopsy from the right knee to establish a diagnosis and we might have to remove one of the nodes from his right groin to take the matter further.¿ (b)(6) 1994: operation.Surgeon: (b)(6) ® knee arthroscopy & synovitis biopsy & inguinal lymph node biopsy.[operative report not provided].(b)(6) 1994: (b)(6) hospital.Report no.(b)(4).¿hospital: (b)(6) hospital.Unit no.(b)(4).Sex: f [sic].D.O.B.(b)(6) 1964.(b)(6).Name: (b)(6).Phys/surg mr (b)(6).Date taken: (b)(6) 1994.Date reported: (b)(6) 1994.Pathologist: (b)(6).Specimen: 1.Tissue (r) knee.2.Tissue from groin.Macro: (1) 2cm.Diameter firm lymph node.(2) triangular piece approximately 15 x 8mm.(1) right knee: there is considerable synovial cell hyperplasia with mild associated acute inflammation.In addition there is a moderate to severe plasma cell infiltrate.There is also numerous macrophages and multinucleate giant cells, some of which appear to contain a non refractile irregular clear granular and angulated substances.(2) tissue from groin: is composed of an enlarged lymph node showing reactive follicular and sinusoidal hyperplasia where there is an increase in plasma cytoid cells.There are in addition diffusely scattered throughout the node a small number of multi nucleate foreign body giant cells containing this clear angulated non refractile material seen in the synovium.These changes appear to be inflammatory and reactive and rheumatoid would have to be considered.I am not completely o fait with goretex synovitis.Could we discuss please?¿ (b)(6) 1994: letter addressed to dr.(b)(6) , consultant pathologist, from dr.(b)(6), dated (b)(6) 1994.¿dear (b)(6) , re: (b)(6) d.O.B.(b)(6) 1964.Thank you for the report on (b)(6) knee.So far we have not seen fragments of gore-tex beyond the knee but the most likely conclusion is that this is so.Your consideration of rheumatoid is interesting as we have seen that on reports before with goretex.His problem is complicated by the fact that he has had two goretex ligaments, the first was an open weave 40,000 strand which broke and is probably the cause of his synovitis, the 2nd is solid and we know that this is still intact without signs of abrasion.I would be happy to discuss it with you particularly the long term complications.¿ yours sincerely, (b)(6) , consultant orthopaedic surgeon.C.C.To mr.(b)(6) , consultant, (b)(6) hospital.C.C.To mr (b)(6) , consultant, (b)(6) hospital¿ (b)(6) 1994: letter addressed to mr.(b)(6) consultant orthopaedic surgeon, from dr.(b)(6) , dated (b)(6) 1994.¿dear (b)(6) , i thought you might be interested in this problem.He had a mark i goretex which ruptured and then a mark ii without rupture.I think the synovitis and fragments in the groin are from the mark i.Yours sincerely, (b)(6), consultant orthopaedic surgeon.¿ 1998: the american journal of sports medicine, vol.26, no.1.© 1998 american orthopaedic society for sports medicine.Lymphadenopathy after gore-tex anterior cruciate ligament reconstruction.Anthony g.Wilson, ¿ fracs, spyridon j.Plessas,¿¿ md, trevor gray,§ fibms, and ian w.Forster,¿ frcs.From the ¿fracture and orthopaedic surgery department and §pathology department, queen¿s medical centre, nottingham, united kingdom.¿the gore-tex (w.L.Gore & associates, flagstaff, arizona) graft was used in humans for about 10 years starting in 1982.During that time thousands of these ligaments were inserted.4 in our hospital, 162 gore-tex cruciate reconstructions were performed between 1986 and 1993 using a standard over-the-top technique.Two of these patients developed inguinal lymphadenopathy secondary to gore-tex particulate materials from the ipsilateral knee joint.To our knowledge, this is the first paper describing the above-mentioned complication, which was established by histologic examination, including electron microscopy.¿ case 1.[alleged as claimant] ¿a 21-year-old man sustained a ruptured acl in his right knee playing soccer in may 1985.In october 1986, an acl reconstruction with a gore-tex i prosthetic graft was performed.Postoperatively, the patient experienced effusion, and, later, developed instability again.The ruptured gore-tex i graft was replaced with a gore-tex cd graft in october 1991.Afterward the knee was stable but a painful effusion developed.In september 1993, inguinal lymphadenopathy was identified in the ipsilateral groin in this patient.In december 1994, the intact gore-tex cd graft was removed, and a superficial inguinal lymph node was excised.Specimens were sent for microbiologic and histologic examination, including electron microscopy.The findings showed a foreign body granulomatous reaction in the lymph node with evident gore-tex fragments.¿ discussion: ¿the original experimental gore-tex prosthetic ligament was a single-filament, expanded-polytetrafluoroethylene (ptfe) prosthesis that was used to replace the acl in animals.Since that time, the original configuration has been changed twice.The gore-tex i graft was an open-weave multifilament design, and the gore-tex cd graft was a sheathed multifilament design.1 changes were made to increase graft strength and compatibility and to reduce the incidence of sterile effusion.The sterile effusion was generally secondary to synovitis.Some reports have noted gore-tex fragments found in the inflamed synovioum, but others have not.4, 5,10 in our department, the incidence of sterile effusion secondary to synovitis was 11.7% (19 cases of 162).This paper demonstrates two cases of gore-tex particles in the inguinal lymph nodes 3 years after the insertion of a gore-tex cd graft in the ipsilateral knee.Metal has been previously found in tissues adjacent to an implant, in the regional lymph nodes, and in the distant lymph nodes, liver, and spleen.2, 8,11 silicon has been found in the lymph glands draining silicon-implanted hand and foot joints.3, 9,12 all these foreign materials exert biologic activity when separated from the main implant in the form of wear particles.Local neoplasms and hematologic malignancies have been described in association with total joint replacement.6,7 until now, however, no such complications have been reported in association with gore-tex insertion, although it has been used for a number of years in vascular surgery.This study demonstrates that gore-tex exercises an effect distant to its site of insertion.Gore-tex was withdrawn from use in ligament surgery in july 1993 because of clinical and economic reasons.However, the complication described here needs further consideration because the onset of the described lymphadenopathy is considered a late complication.Presently, prosthetic polyester ligaments are available and being inserted in significant numbers for other purposes.These ligaments may be very successful.However, we suggest that their use should be restricted to cases where other methods of reconstruction cannot be applied.¿ it should be noted that the gore-tex® cruciate ligament instructions for use include warnings and addresses the following adverse reactions among others: ¿the following intraoperative and postoperative complications have been reported: 1.Inflammatory effusion.2.Failure of the device or recurrent instability of the joint both events can result from improper implantation or inadequate tensioning.3.Soft tissue irritation associated with fixation screws.4.Deep and superficial infection.5.Loosening of fixation screws.6.Fibrous ankylosis.7.Fractures possibly associated with bone tunnels or screw holes.8.Neurovascular damage during implantation.¿ the instructions for use further warn: ¿arthroscopic examination of patients implanted with this device have shown evidence of broken strands.The effect of these broken strands on the long-term performance of the device is unknown at this time.The long-term biologic effect of ptfe particulate, released due to abrasion of the device, and the foreign body reaction to this particulate, is not known at this time; the risks associated with ptfe particulate may increase with multiple implantations of the device.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.On (b)(6) 1985: letter addressed to dr.(b)(6), (b)(6) from (b)(6).Admitted: (b)(6) 1985.Discharged: (b)(6) 1985.¿this 21-year-old man was admitted from the fracture clinic on (b)(6) 1985 complaining that six weeks previous he had undergone a flexion/twisting injury to the right knee whilst playing football and since then had persistent discomfort over the antero-medial compartment with a clicking sensation when walking, and had been unable to fully extend the knee for 24 hours.He was examined under an anesthetic when his knee was found to be locked in 10° flexion with a positive lachman¿s sign and a valgus laxity.Arthroscopy revealed complete rupture of the anterior cruciate in the mid-upper third substance.This was not repaired.He made an uneventful recovery and was allowed home on (b)(6) 1985 with a fracture clinic appointment in 2 weeks.¿ on (b)(6) 1989: [facility not indicated] gg/gac/t.Clinical notes: ¿review of 27 months following r.Goretex acl reconstruction.He remains in status quo, that is to say he has very little pain or discomfort although he has some feeling of insecurity.He has not returned to any form of sport although asked today if it would be safe to take up cycling.Assessment forms completed.In essence he has a cool and dry knee with a full range of movement and minimally increased anterior drawer and lachman test.There is no increased medial or lateral laxity, and no pivot shift.The right quads are a little down compared with the left.X ray of his right is essentially unremarkable with no joint space diminution.Advised that he may safely return to non contact sports and we will see in one year or sooner if necessary.¿ on (b)(6) 1990: [facility not indicated] iwf/aeh/t.Clinical notes: ¿this chap is superb one year after his operation.Form filled in today.Review again in a year's time.¿ on (b)(6) 1991: letter addressed to dr (b)(6), from dr (b)(6).¿dear dr (b)(6), (b)(6) tore his right knee acl in a football injury in 1984.He underwent a goretex reconstruction of tails ligament in 1986, and for the last eighteen months has been complaining of a sensation of valgus instability.He was admitted as a day case for arthroscopy of the right knee, which unfortunately revealed a complete rupture of his gortex reconstruction.The knee was washed out, and he was discharged his crepe bandage and on crutches.We will review him in the clinic in two weeks¿ time.¿ on (b)(6) 1991: (b)(6) health authority, gv/gac/t.Clinical notes: ¿this chap has been improved by his arthroscopy although still has intermittent episodes of instability where he feels his medial condyle is sliding forward on his medial tibial condyle.There is no effusion, full leg movement and is walking normally.For him to continue light exercises and see in four weeks - clinic check.¿ on (b)(6) 1991: (b)(6) health authority, iwf/gac.Clinical notes: ¿this chap has been made redundant as he failed a medical.He has a ruptured goretex and this should be replaced with a mark ii.To go ont [sic] the urgent list to have this done.On (b)(6) 1991: (b)(6) health authority, ar/smw.Clinical notes: ¿this man's goretex mark i on the right side was performed 5 years ago and has gradually become less effective to the extent that he is now unable to get work because of his knee and is unable to take part in any sports.His goretex wounds are well healed.He has a range of movements from approximately 5° to 130°, slight effusion.No patellofemoral crepitus.No joint line tenderness.Grade 1 lachmann¿s, 1-2 anterior drawer, 0 pcl.Grade 0-1 mcl.¿ on (b)(6) 1991: [facility not indicated] seen on the ward round by mr (b)(6).Progress note: ¿he has developed a bit of a haematoma in the lateral wound and this, along with a spiking pyrexia, have got in the way of his limited mobilization attempts.He has a range of flexion from 10 - 40° and this has not been aggressively pursued as yet.He has a circumferential burn around the right upper thigh relating presumably to the tourniquet.He has now one week following the procedure, marked blistering area posteromedially extending up to the mid-line anteriorly.I am not certain as to the cause of this but i suspect this is due to the tourniquet.I have apologized to him about this.I anticipate that he will be mobilising soon [sic] and that he will be able to go home either end of this or beginning of next week.See in clinic in two weeks time.¿ on (b)(6) 1991: discharged: to be seen in mr.(b)(6) clinic at (b)(6) medical center on tuesday (b)(6) 1991 at 1.45pm.Removal of sutures.On (b)(6) 1991: letter addressed to dr.(b)(6), from (b)(6) orthopaedic hospital, mr (b)(6), senior registrar to mr (b)(6).Dear dr (b)(6): your patient, (b)(6), was admitted on the (b)(6) 1991 for a re-do of his right goretex anterior cruciate ligament performed in 1986.On the (b)(6) 1991 we performed revision of his right goretex acl.Post-operatively he developed a bit of a haematoma in the lateral wound, a spiking pyrexia and marked blistering.His mobilising was therefore delayed.He was discharged home on the (b)(6) 1991 and will be reviewed in mr.(b)(6) out-patient clinic at (b)(6) medical center on the (b)(6) 1991 at which time his sutures will be removed.¿ on (b)(6) 1991: [facility not indicated] ar/gaf/t.¿(b)(6) is now 3 weeks following his revision of r goretex mark i to ii, grade i effusion in knee.Very nicely healed wounds.Block of 10° to extension.Work at this in physio.¿ on (b)(6) 1991: [facility not indicated] iwf/gaf.¿he has still got an effusion.He is having treatment at (b)(6).Continue and see in 7 weeks.¿ on (b)(6) 1992: [facility not indicated] iwf/gaf.¿(b)(6) is doing very well.Slight effusion.Would like to look for a job now and this is very reasonable.See in six weeks period to continue exercising and go swimming.¿ on (b)(6) 1992: [facility not indicated] iwf/gaf/t.¿has quite a persistent effusion, but is moving the knee very well.Is able to run on it but has swelling thereafter.Lasts for a day.We ought to let him carry on as he wishes for the moment and should review in six weeks¿ time in pkc.¿ on (b)(6) 1992: [facility not indicated] iwf/gaf.¿quite a large effusion in the knee which is troubling him.Came on particularly after exercise.He should ice the knee and it feels stable to examination.See in two months.¿ on (b)(6) 1992: [facility not indicated] pjr/gaf/t.¿still not particularly happy following his revision goretex acl in (b)(6) 1991.He has persistent swelling around the knee and find difficulty in fully extending it and fully flexing it because of discomfort.Also feels a clicking, catching sensation anteromedially.There is slight reddening around the distal tibial screw but no particular sign of infection.He is not particularly tender over it.His knees does not fully extend by around 5° and he finds difficulty in flexing more than 100° in the clinic.There is some diffuse swelling but no inflammation.X-rays show some degenerative changes particularly lfc and osteophyte lipping there.I have asked for a further course of physiotherapy including (b)(6) if they wish and also have said to him we could arthroscope his knee to see the joint with the current state of degenerative changes.Try to get this done at (b)(6) within the next few months.Given an appointment for clinic in six months.¿ on (b)(6) 1992: [facility not indicated] iwf/gaf.¿he is currently waiting for an arthroscopy.There has been no giving way but the principal problem is swelling posteromedially.Knee feels stable to examination.¿ on (b)(6) 1993: (b)(6) health authority, mr (b)(6).Clinical notes: ¿admitted for diagnostic arthroscopy of the right knee.He has had a revision gortex acl in (b)(6) 1991 and since that time, has had persistent swelling in the knee and feels some catching on the anterio-medial aspect of the right knee joint.¿ on (b)(6) 1993: (b)(6) health authority, illegible signature, to mr.(b)(6).Discharge from hospital with diagnosis of painful right knee.Treatment in hospital: right knee arthroscopy, tear in lateral meniscus, removed through arthroscope.Gortex intact.To be seen at out-patients in 2 weeks.Patient should be fit to attend your surgery.On (b)(6) 1993: (b)(6) health authority, iwf/gaf.Clinical notes: ¿he has got some swelling of the knee but it is much better than it was having had the meniscectomy.We are due to do his follow up but we will leave it at this stage in view of the latest op.See in six weeks.¿ on (b)(6) 1993: letter addressed to dr.(b)(6), from (b)(6) orthopaedic hospital, mr (b)(6)i, senior registrar to mr (b)(6).Admitted: (b)(6) 1993.Discharged: (b)(6) 1993.¿history: for diagnostic arthroscopy of his right knee following a revision goretex acl in 1991 since which time he has had persistent swelling in the knee and some catching on the anteromedial aspect of the right knee joint.Operation: eua/arthroscopy and menisectomy of the right knee on (b)(6) 1993.Follow up: he has subsequently been reviewed in the clinic at (b)(6) by mr (b)(6).¿ on (b)(6) 1993: (b)(6) health authority, iwf/gaf.Clinical notes: ¿still has nipping following his arthroscopy and still some fluid in the knee.Allow to settle further.See in six weeks.¿ on (b)(6) 1993: (b)(6) health authority, ma/mo¿c/t, (b)(6), senior orthopaedic registrar.Clinical notes: ¿this 29 year old, currently unemployed patient, who injured his knee with a football injury in 1984 underwent an [sic] knee reconstruction in 1986 using goretex i.Unfortunately this failed and according to (b)(6) has been revised in 1991 to a goretex ii.He has been under constant review but unfortunately his notes in fact are incomplete and there is no evidence of him being seen since (b)(6) 1991.He complains of constant ache and swelling today and denies any episodes of instability.He does however have regular clicking within the knee and in fact he had episodes of locking last year and underwent a further arthroscopy around (b)(6) in 1992 where he describes a menisectomy.On examination he has some minor wasting of his quadriceps only.There are surgical scars about the knee consistent with goretex reconstruction.Clinically, he has a large effusion the knee is slightly warm to touch, he has full extension but flexion is restricted to approximately 110° in comparison to the left which is normal.There are palpable groin nodes and i just wonder whether in fact he has a grumbling infection.I have asked for an fbd [?] and 5sr today and will arrange a bone scan of his right knee today.I will see him with he results and plain films in the next few weeks.¿ on (b)(6) 1993: letter addressed to sir/madam, medical physics, a floor, uhn, (b)(6), senior orthopaedic registrar.¿i would be grateful if you could arrange an early appointment for this young man for a technician bone scan looking at this right knee in particular.Unfortunately, he has had to have a revision of his right goretex knee reconstruction and the concern here is that this is infected.I am sure the patient would be grateful for an early appointment.¿ (b)(6) 1994: operation note on (b)(6).Operation: eua/arthroscopy right knee and excision of inguinal lymph node surgeon: mr (b)(6).Assistant: mr (b)(6).¿on eua lachaman 1, anterior drawer negative and pivot negative.Patella tap was positive.Tourniquet applied and inflated.Usual anterior lateral entry for 30° scope and anterior medial entry point for probe and instrumentation.When the scope was put in about 40 ml of straw colored fluid came out which was sent for microscopy and culture and sensitivity there was a lot of synovitis around the suprapatella pouch and in both parapatella gutters.There was some fibrillation involving medial facet of the patella.Both menisci were intact to visualisation and probing.Goretex implant was very stable on probing and on manipulating the knee there was no giving way.It did not show any signs of abrasion.There was grade 1-2 articular defect involving the medial femoral condyle, both tibial plateaus were normal but again there was a lot of synovitis all around.A biopsy of synovium was taken using pituatory forceps.We fully irrigated and washed.Wool and crepe applied.Tourniquet deflated.Patient draped again - and a small transverse incision made over the inguinal lymph node, one of the superficial lymph node looked very beefy and enlarged excised.Affront and effront vessels to this lymph node tied, lymph node sent for histopathological examination.Wound closed in layers.3/0 ethilon to skin.¿ post op instructions: can go home when comfortable.Sutures can be removed from the inguinal region in 2 weeks time.Review out-patients in 3 weeks time.Discharged (b)(6) 1994.¿to be seen in mr.(b)(6) clinic at (b)(6) on (b)(6) 1994 @ 2:15pm.¿ on (b)(6) 1994: letter addressed to dr.(b)(6), from (b)(6) orthopaedic hospital, mr (b)(6), senior registrar to mr (b)(6).Admitted: (b)(6) 1994.Discharged: (b)(6) 1994.History: he had a goretex acl reconstruction twice to his right knee.The knee gives him constant pain now.Operation: on the (b)(6) 1994, he underwent eua/arthroscopy and right knee and excision of the inguinal lymph node.Arthroscopy demonstrated synovitis around the suprapatella pouch.The goretex was stable.A biopsy of synovium was taken.Follow up: mr (b)(6) clinic at (b)(6) on (b)(6) 1994.¿ on (b)(6) 1994: letter addressed to mr (b)(6), consultant orthopaedic surgeon, from dr.(b)(6).¿dear (b)(6), i thought you might be interested in this problem.He had a mark i goretex which ruptured and then a mark ii without rupture.I think the synovitis and fragments in the groin are from the mark i.Yours sincerely, (b)(6), consultant orthopaedic surgeon¿.On (b)(6) 1994: [facility not indicated] operation notes for (b)(6).Procedure: arthroscopic synovectomy right knee.Surgeon: mr (b)(6).Assistants: dr (b)(6), dr (b)(6).Operation: tourniquet.Arthroscopic portals involved in both suprapatellar, infrapatellar and mid patellar sites.Synovitis [sic] not particularly widespread anywhere but certainly some in the supra patellar pouch, some around both menisci superiorly and very little in the actual gutters themselves.All this was cleared out relatively easily with the 5.5 shaver and 5.5 gator blade on the shaver.It was noticed that there was a grade 3 lesion on the lateral femoral condyle which i shaved and there were osteophytes on the medial femoral condyle which i left alone.There was also grade 2 changes on the surface of the lateral tibial condyle and the lateral meniscus was very ragged although there still was a remnant across the popliteus tunnel.It was possible for me to shave down the popliteus tunnel and this was also clear.All the tissue removed was kept for histology and culture.Redivac drain inserted, wool, crepe, to go on cpm machine after.The goretex was noted to be clear.There was not a lot of intercondylar synovitis but what there was there was removed along with other scar tissue and it was seen that the notch was very clear.Single dose of antibiotics given at the end of the operation.¿.
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