STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #5 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Model Number 5531-G-511-E |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Fibrosis (3167); Swelling/ Edema (4577)
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Event Date 06/23/2022 |
Event Type
Injury
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Manufacturer Narrative
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An event regarding rom involving an unknown triathlon knee was reported.The event was confirmed via clinician review of the provided medical records.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a review of the provided medical information by a clinical consultant indicated: "conclusion/assessment: the patient had a poor knee range of motion postoperatively which led to mua and arthroscopic lysis of adhesions.He remains dissatisfied and is considering a revision surgery.Event confirmation: poor postoperative range of motion, mua and lysis of adhesions via an arthroscope can be confirmed.Root cause: a root cause cannot be determined with the records provided." -product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient underwent medical intervention to address range of motion issues.The event was confirmed through clinician review of the provided medical records.The exact cause of the event could not be determined because insufficient information was provided.Further information such as device-identifying information (catalog number and lot code), pathology reports, pre- and post-operative x-rays as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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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Patient reported having a right knee manipulation under anesthesia and arthroscopic lysis of adhesions due to arthrofibrosis on (b)(6) 2022.Update: spoke with patient who stated that he will be seeing his doctor on (b)(6) 2023 to determine if a revision will be done.Patient states he is "leaning towards having the revision done as he is experiencing back and bilateral hip pain".
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Manufacturer Narrative
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Corrected data: device information.An event regarding rom involving a triathlon insert was reported.The event was confirmed via clinician review of the provided medical records.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.Clinician review: a review of the provided medical information by a clinical consultant indicated: "conclusion/assessment: the patient had a poor knee range of motion postoperatively which led to mua and arthroscopic lysis of adhesions.He remains dissatisfied and is considering a revision surgery.Event confirmation: poor postoperative range of motion, mua and lysis of adhesions via an arthroscope can be confirmed.Root cause: a root cause cannot be determined with the records provided." product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient underwent medical intervention to address range of motion issues.The event was confirmed through clinician review of the provided medical records.The exact cause of the event could not be determined because insufficient information was provided.Further information such as device lot code, pathology reports, pre- and post-operative x-rays as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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.The following devices were also listed in this report: triathlon p/a cr beaded #5r; cat# 5517f502; lot# unknown.Tritanium bplate triathlon s5; cat# 5536b500; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
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Event Description
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Patient reported having a right knee manipulation under anesthesia and arthroscopic lysis of adhesions due to arthrofibrosis on (b)(6) 2022.Update: spoke with patient who stated that he will be seeing his doctor on (b)(6) 2023 to determine if a revision will be done.Patient states he is "leaning towards having the revision done as he is experiencing back and bilateral hip pain".
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Search Alerts/Recalls
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