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STRYKER ORTHOPAEDICS-MAHWAH MRH KNEE FEM S LFT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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| Model Number 6481-1-110 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Wound Dehiscence (1154); Fistula (1862); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Metal Related Pathology (4530); Osteomyelitis (4533)
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| Event Date 09/16/2021 |
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Event Type
Injury
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Manufacturer Narrative
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An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
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Event Description
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The customer reported that: "product: ptg type gmrs stryker (installed in 2018) dear madam/sir, one of your knee prosthesis has been the subject of a case of exposure recorded by the french poison control and toxicovigilance centers.In accordance with article r1341-2 of the french public health code, we would be grateful if you could provide us with the following information as soon as possible - the complete qualitative and quantitative composition at 100%: o to remove any ambiguity, each substance will be identified by a cas or en number, o the concentration of each substance will be designated quantitatively by a precise concentration or semi-quantitatively by an acceptable concentration range.O if some of the components of your mixture are themselves included mixtures supplied by other manufacturers, they should be listed in the composition under their trade name and the corresponding safety data sheet should be provided to us.This information is essential for us to evaluate the risks and to propose an adapted medical care for the exposed persons who are in situations very far from the expected use of the mentioned mixture." "this case is a bit special because the patient concerned had an infection of her prosthesis in 2018 (old case), and new symptoms appeared during (b)(6) 2021.As a result, several hypotheses have been put forward, including a suspicion of metallosis.Blood tests were performed on this patient and some metals were slightly higher than normal.As the patient's treatment in 2018 took place in another region and we were not requested at that time, we do not have any information concerning the prosthesis: no reference, no batch number, and the product is no longer available.We have come to you to find out, if possible, the exact composition of the prosthesis (level of metals such as cobalt, chromium, barium, zirconium, etc.) in order to determine whether or not metallosis is suspected.".
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Manufacturer Narrative
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An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
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Event Description
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The customer reported that: "product: ptg type gmrs stryker (installed in 2018) dear madam/sir, one of your knee prosthesis has been the subject of a case of exposure recorded by the french poison control and toxicovigilance centers.In accordance with article r1341-2 of the french public health code, we would be grateful if you could provide us with the following information as soon as possible - the complete qualitative and quantitative composition at 100%: o to remove any ambiguity, each substance will be identified by a cas or en number, o the concentration of each substance will be designated quantitatively by a precise concentration or semi-quantitatively by an acceptable concentration range.O if some of the components of your mixture are themselves included mixtures supplied by other manufacturers, they should be listed in the composition under their trade name and the corresponding safety data sheet should be provided to us.This information is essential for us to evaluate the risks and to propose an adapted medical care for the exposed persons who are in situations very far from the expected use of the mentioned mixture." "this case is a bit special because the patient concerned had an infection of her prosthesis in 2018 (old case), and new symptoms appeared during (b)(6) 2021.As a result, several hypotheses have been put forward, including a suspicion of metallosis.Blood tests were performed on this patient and some metals were slightly higher than normal.As the patient's treatment in 2018 took place in another region and we were not requested at that time, we do not have any information concerning the prosthesis: no reference, no batch number, and the product is no longer available.We have come to you to find out, if possible, the exact composition of the prosthesis (level of metals such as cobalt, chromium, barium, zirconium, etc.) in order to determine whether or not metallosis is suspected.".
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Manufacturer Narrative
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A3 correction: the patient is male not female.An event regarding infection, wear/metallosis, and abnormal ion level involving a mrh femoral component was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: "the question at hand appears to be related to possible metal toxicity related to the knee implants.As reported at the time of component explantation no mention is made of metallosis which might lead to suspicion of toxicity.Chromium and cobalt levels reportedly obtained 3 years post component explantation and amputation were near and at normal levels respectively.(the plasma chromium level is discretely increased to 227 iu/l and the plasma cobalt plasma levels were normal at 7.9 nmol/l) there is no evidence provided establishing metallic ion toxicity." -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot or sterile lot referenced.Conclusions: it was reported that the patient was amputated after the implantation of stryker devices.Infection, metallosis, and abnormal ion levels were reported.A review of the provided medical records by a clinical consultant indicated the following: "the question at hand appears to be related to possible metal toxicity related to the knee implants.As reported at the time of component explantation no mention is made of metallosis which might lead to suspicion of toxicity.Chromium and cobalt levels reportedly obtained 3 years post component explantation and amputation were near and at normal levels respectively.(the plasma chromium level is discretely increased to 227 iu/l and the plasma cobalt plasma levels were normal at 7.9 nmol/l).There is no evidence provided establishing metallic ion toxicity." the exact cause of the event could not be determined because insufficient information was provided.It was reported that the patient has a long-standing history of chronic septic infection (beginning with the implantation of competitor devices) along with a variety of other patient factors that may have contributed to the event.All stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.From the information provided, the reported event cannot be conclusively linked to stryker devices.Additionally, the stryker materials team reviewed the event and provided the following information regarding device material composition: "this product is composed of a single metal alloy: cobalt-28chromium-6molybdenum cast alloy for surgical implants, compliant with astm f75." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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The customer reported that: "product: ptg type gmrs stryker (installed in 2018) dear madam/sir, one of your knee prosthesis has been the subject of a case of exposure recorded by the french poison control and toxicovigilance centers.In accordance with article r1341-2 of the french public health code, we would be grateful if you could provide us with the following information as soon as possible - the complete qualitative and quantitative composition at 100%: o to remove any ambiguity, each substance will be identified by a cas or en number, o the concentration of each substance will be designated quantitatively by a precise concentration or semi-quantitatively by an acceptable concentration range.O if some of the components of your mixture are themselves included mixtures supplied by other manufacturers, they should be listed in the composition under their trade name and the corresponding safety data sheet should be provided to us.This information is essential for us to evaluate the risks and to propose an adapted medical care for the exposed persons who are in situations very far from the expected use of the mentioned mixture." "this case is a bit special because the patient concerned had an infection of her prosthesis in 2018 (old case), and new symptoms appeared during june 2021.As a result, several hypotheses have been put forward, including a suspicion of metallosis.Blood tests were performed on this patient and some metals were slightly higher than normal.As the patient's treatment in 2018 took place in another region and we were not requested at that time, we do not have any information concerning the prosthesis: no reference, no batch number, and the product is no longer available.We have come to you to find out, if possible, the exact composition of the prosthesis (level of metals such as cobalt, chromium, barium, zirconium, etc.) in order to determine whether or not metallosis is suspected." update: "38 year old patient who had a prosthetic implant at the age of 15 years of age, implanted with a knee prosthesis knee prosthesis in 1998 for an osteosarcoma of the left lower limb (reference not known).In february 2018, he was treated for sepsis on a total knee prosthesis, which was changed in one step on 07/02/2018 (reference not known).A delay in healing was observed on multiple infections requiring several lines of lines of antibiotics.A revision of a left total knee prosthesis total knee prosthesis was performed in 2 stages, with removal of the prosthesis and insertion of a spacer in spacer in june 2018 and replacement of the prosthesis type gmrs on 10/08/2018.On this date, at the time of the prosthesis, the operative report did not mention any of any metallosis-type deposits in the articular level.On 22/08/2018, a new delay in healing was observed with disunion of the scar, despite the antibiotic therapy in place.The evolution is unfavourable with the constitution of cicatricial fistulas.On 18/10/2018 the patient underwent a transfemoral amputation due to the of healing and the persistence of fistulas.In mid-december 2018, a new delay in the healing process of healing is noted with the identification of a focus of osteitis at the distal end of the stump.On 14/02/2019: resumption of the amputation with recutting of the bone at 11 cm above an internal cortical erosion.Favourable evolution with braces.May 2019: appearance of a swelling inguinal swelling.December 2020: the management is continued in internal medicine for internal medicine for assessment of hypermetabolic left iliac and inguinal adenomegaly inguinal adenomegaly with no other cause other than metallosis according to the pathological findings.The plasma chromium level is discretely increased to 227 iu/l and the plasma cobalt plasma levels were normal at 7.9 nmol/l in june 2021, almost 3 years after the amputation.The explanted devices are no longer available for analysis.
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Event Description
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The customer reported that: "product: ptg type gmrs stryker (installed in 2018) dear madam/sir, one of your knee prosthesis has been the subject of a case of exposure recorded by the french poison control and toxicovigilance centers.In accordance with article r1341-2 of the french public health code, we would be grateful if you could provide us with the following information as soon as possible - the complete qualitative and quantitative composition at 100%: to remove any ambiguity, each substance will be identified by a cas or en number, the concentration of each substance will be designated quantitatively by a precise concentration or semi-quantitatively by an acceptable concentration range.If some of the components of your mixture are themselves included mixtures supplied by other manufacturers, they should be listed in the composition under their trade name and the corresponding safety data sheet should be provided to us.This information is essential for us to evaluate the risks and to propose an adapted medical care for the exposed persons who are in situations very far from the expected use of the mentioned mixture." "this case is a bit special because the patient concerned had an infection of her prosthesis in 2018 (old case), and new symptoms appeared during (b)(6) 2021.As a result, several hypotheses have been put forward, including a suspicion of metallosis.Blood tests were performed on this patient and some metals were slightly higher than normal.As the patient's treatment in 2018 took place in another region and we were not requested at that time, we do not have any information concerning the prosthesis: no reference, no batch number, and the product is no longer available.We have come to you to find out, if possible, the exact composition of the prosthesis (level of metals such as cobalt, chromium, barium, zirconium, etc.) in order to determine whether or not metallosis is suspected." update: "38 year old patient who had a prosthetic implant at the age of 15 years of age, implanted with a knee prosthesis knee prosthesis in 1998 for an osteosarcoma of the left lower limb (reference not known).In (b)(6) 2018, he was treated for sepsis on a total knee prosthesis, which was changed in one step on (b)(6) 2018 (reference not known).A delay in healing was observed on multiple infections requiring several lines of lines of antibiotics.A revision of a left total knee prosthesis total knee prosthesis was performed in 2 stages, with removal of the prosthesis and insertion of a spacer in spacer in (b)(6) 2018 and replacement of the prosthesis type gmrs on (b)(6) 2018.On this date, at the time of the prosthesis, the operative report did not mention any of any metallosis-type deposits in the articular level.On (b)(6) 2018, a new delay in healing was observed with disunion of the scar, despite the antibiotic therapy in place.The evolution is unfavourable with the constitution of cicatricial fistulas.On (b)(6) 2018 the patient underwent a transfemoral amputation due to the of healing and the persistence of fistulas.In (b)(6) 2018, a new delay in the healing process of healing is noted with the identification of a focus of osteitis at the distal end of the stump.On (b)(6) 2019: resumption of the amputation with recutting of the bone at 11 cm above an internal cortical erosion.Favourable evolution with braces.(b)(6) 2019: appearance of a swelling inguinal swelling.(b)(6) 2020: the management is continued in internal medicine for internal medicine for assessment of hypermetabolic left iliac and inguinal adenomegaly inguinal adenomegaly with no other cause other than metallosis according to the pathological findings.The plasma chromium level is discretely increased to 227 iu/l and the plasma cobalt plasma levels were normal at 7.9 nmol/l in (b)(6) 2021, almost 3 years after the amputation.The explanted devices are no longer available for analysis.
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Manufacturer Narrative
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The following devices were also listed in this report: kx+ duration patella med; cat # 64794911; lot # lgc950 gmrs tibial insert small 10mm; cat # 64953010; lot # len412 mrhk fem distal blk 10mm s; cat # 64811210; lot # cb46a mrhk fem distal blk 10mm s; cat # 64811210; lot # cp76h gmrs tib rotating sml comp; cat # 64953601; lot # 114956 mrs fem stem w/o body 15x203mm; cat # 64853615; lot # 130109a gmrs proximal tib sml; cat # 64953101; lot # 097667j mrh hdp assembly pack; cat # 64812150; lot # lhe063 gmrs extension piece 30mm; cat # 64956030; lot # dnx3d dcon p-fit stem cocr16mmx155mm; cat # 64786445; lot # ehp3m mrh axle; cat # 64812120; lot # ctd27136 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding infection, wear/metallosis, and abnormal ion level involving a mrh femoral component was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: "the question at hand appears to be related to possible metal toxicity related to the knee implants.As reported at the time of component explantation no mention is made of metallosis which might lead to suspicion of toxicity.Chromium and cobalt levels reportedly obtained 3 years post component explantation and amputation were near and at normal levels respectively.(the plasma chromium level is discretely increased to 227 iu/l and the plasma cobalt plasma levels were normal at 7.9 nmol/l) there is no evidence provided establishing metallic ion toxicity." -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot or sterile lot referenced.Conclusions: it was reported that the patient was amputated after the implantation of stryker devices.Infection, metallosis, and abnormal ion levels were reported.A review of the provided medical records by a clinical consultant indicated the following: "the question at hand appears to be related to possible metal toxicity related to the knee implants.As reported at the time of component explantation no mention is made of metallosis which might lead to suspicion of toxicity.Chromium and cobalt levels reportedly obtained 3 years post component explantation and amputation were near and at normal levels respectively.(the plasma chromium level is discretely increased to 227 iu/l and the plasma cobalt plasma levels were normal at 7.9 nmol/l).There is no evidence provided establishing metallic ion toxicity." the exact cause of the event could not be determined because insufficient information was provided.It was reported that the patient has a long-standing history of chronic sceptic infection (beginning with the implantation of competitor devices) along with a variety of other patient factors that may have contributed to the event.All stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.From the information provided, the reported event cannot be conclusively linked to stryker devices.Additionally, the stryker materials team reviewed the event and provided the following information regarding device material composition: "this product is composed of a single metal alloy: cobalt-28chromium-6molybdenum cast alloy for surgical implants, compliant with astm f75." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
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