STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Model Number 5520-B-400 |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Ambulation Difficulties (2544); Inadequate Osseointegration (2646)
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Event Date 08/25/2021 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
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Event Description
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It was reported that the patient's right knee was revised.Patient presented in severe varus due to tibial baseplate loosening.Intra-operatively, it was noticed that the insert had cracked medially posteriorly.
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Event Description
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It was reported that the patient's right knee was revised.Patient presented in severe varus due to tibial baseplate loosening.Intra-operatively, it was noticed that the insert had cracked medially posteriorly.
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Manufacturer Narrative
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Reported event: an event regarding loosening involving a triathlon baseplate was reported.The event was not confirmed.Method & results: -device evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photograph shows a recently explanted triathlon prim tib baseplate ¿ cemented with damage consistent with attempted implantation/explantation.A piece of the polyethylene insert appears to remain attached to the top of the baseplate.The photograph does not show any damage indicative of baseplate loosening.Material analysis: not performed as the device was not returned.Dimensional inspection: not performed as the device was not returned.Functional inspection: not performed as the device was not returned.-clinician review: no medical records were received for review with a clinical consultant.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: no other similar events were reported for the lot.Conclusion: visual inspection of the device photographs indicated damage to the device consistent with attempted implantation/explantation.The visual inspection did not confirm the reported loosening of the tibial baseplate.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
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