STRYKER ORTHOPAEDICS-MAHWAH TRI CEMENTED STEM 12MMX50MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5560-S-112 |
Device Problem
Osseointegration Problem (3003)
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Patient Problems
Injury (2348); Inadequate Osseointegration (2646)
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Event Date 02/07/2017 |
Event Type
Injury
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Manufacturer Narrative
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If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.
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Event Description
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Medical records provided for legal pi have indicated additional treatments/revisions the patient underwent.This pi is for a second revision surgery the patient underwent on 07 feb 2017 due to baseplate/tibial stem loosening.Excerpt from medical review: "loosening of the triathlon baseplate with associated stem extender was confirmed while femoral and patellar components proved to be well fixed and were as such retained." ¿the use of a relatively short 50-mm stem extender below an augment in a proximal tibial bone defect condition did not provide adequate stability to the newly implanted baseplate during the previous revision with excessive micromotion in the implant-bone interface resulting in early loosening requiring a second revision within short interval.".
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Event Description
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Medical records provided for legal pi have indicated additional treatments/revisions the patient underwent.This pi is for a second revision surgery the patient underwent on (b)(6) 2017 due to baseplate/tibial stem loosening.Excerpt from medical review: "loosening of the triathlon baseplate with associated stem extender was confirmed while femoral and patellar components proved to be well fixed and were as such retained.".¿the use of a relatively short 50-mm stem extender below an augment in a proximal tibial bone defect condition did not provide adequate stability to the newly implanted baseplate during the previous revision with excessive micromotion in the implant-bone interface resulting in early loosening requiring a second revision within short interval.".
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Manufacturer Narrative
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An event regarding loosening involving a triathlon tibial stem was reported and confirmed through a medical review for this patient.Method & results: device evaluation and results: not performed as product was not returned clinician review: a review of the provided medical records by a clinical consultant indicated: the use of a relatively short 50-mm stem extender below an augment in a proximal tibial bone defect condition did not provide adequate stability to the newly implanted baseplate during the previous revision with excessive micromotion in the implant bone interface resulting in early loosening requiring a second revision within short interval.Clinical suspicion for presence of a lowgrade infection in the implant-bone interface, although notexplicitly proven, may have accelerated the baseplate fixation failure.Excess bone removal as required for removal of well-fixed cemented pkr baseplate during the first revision of (b)(6) 2016.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: a review of the provided medical records by a clinical consultant indicated: the use of a relatively short 50-mm stem extender below an augment in a proximal tibial bone defect condition did not provide adequate stability to the newly implanted baseplate during the previous revision with excessive micromotion in the implant bone interface resulting in early loosening requiring a second revision within short interval.Clinical suspicion for presence of a lowgrade infection in the implant-bone interface, although notexplicitly proven, may have accelerated the baseplate fixation failure.Excess bone removal as required for removal of well-fixed cemented pkr baseplate during the first revision of (b)(6) 2016.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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Search Alerts/Recalls
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