STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S6; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5536B600 |
Device Problems
Collapse (1099); Osseointegration Problem (3003)
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Patient Problem
Pain (1994)
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Event Date 08/23/2016 |
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 due to hospital policy.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
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Event Description
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Patient had a painful knee and x-ray revealed a collapsed tibial baseplate.
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Manufacturer Narrative
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An event regarding tibial loosening involving a tritanium baseplate was reported.The event was confirmed.Method & results: device evaluation and results: one photograph of the explanted devices was attached.The baseplate appears to have tissue attached.The insert appears unremarkable.Medical records received and evaluation: the tritanium baseplate is grossly loose and has dropped into varus position with lateral bone lift-off.Posterior tibial slope appears still adequate.Original tibial baseplate position cannot be evaluated due to gross change in position after loosening.Available post event x-rays document gross baseplate loosening with varus dislocation and lateral bone lift-off.The explant photograph shows only adherent fibrous tissue as sign of fixation failure through lack of bone ingrowth.The poly bearing shows no obvious pathology.Device history review: the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: medical review confirms baseplate loosening however the exact root cause could not be determined because insufficient medical information was provided.Further information such as product return, early post implantation x-rays, operative notes, patient history and follow-up notes are needed to complete the investigation for determining a root cause.A capa trend analysis was conducted for the reported failure mode and concluded tritanium baseplate loosening may result from factors not related to the device.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.
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Event Description
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Patient had a painful knee and x-ray revealed a collapsed tibial baseplate.
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Search Alerts/Recalls
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