STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S2; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5536B200 |
Device Problem
Migration (4003)
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Patient Problems
Injury (2348); Ambulation Difficulties (2544)
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Event Date 06/02/2020 |
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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It was reported that the patient's right knee was revised due to subsidence of the tibial baseplate.Intra-operatively, it was noted that the baseplate is fractured.The baseplate and liner were revised.No allegations against the revised liner were reported.
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Manufacturer Narrative
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An event regarding crack/fracture and subluxation involving a triathlon baseplate was reported.The event was confirmed by medical records.Method & results: device evaluation and results: visual inspection of images was performed and stated that - device seems to break with yellowish material on device surface.Functional, dimensional and material analysis not performed as device was not returned.Clinician review: a review of the provided medical records and/or x-rays by a clinical consultant stated that : there was varus collapse and subluxation of the tibial component as well as a baseplate fracture.The collapse and metal fracture necessitated a revision surgery.The fracture was likely due to fatigue as a result of micro motion associated with failure to in-growl medially.Obtaining the implant may provide insight into the mechanism of failure.Device history review: all 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 reported lot.Conclusion: it was reported that patient right knee was revised due to crack/fracture and subluxation.Visual inspection of images was performed and stated that - device seems to break with yellowish material on device surface.A review of the provided medical records and/or x-rays by a clinical consultant stated that : there was varus collapse and subluxation of the tibial component as well as a baseplate fracture.The collapse and metal fracture necessitated a revision surgery.The fracture was likely due to fatigue as a result of micro motion associated with failure to in-grow medially.Obtaining the implant may provide insight into the mechanism of failure.The exact cause of the event could not be determined because insufficient information was provided.Additional information including progress notes and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
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Event Description
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It was reported that the patient's right knee was revised due to subsidence of the tibial baseplate.Intra-operatively, it was noted that the baseplate is fractured.The baseplate and liner were revised.No allegations against the revised liner were reported.
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Search Alerts/Recalls
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