An event regarding tibial loosening involving a triathlon augment was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: not performed as medical records were not provided.Product history review: indicated all devices were 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: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays 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.Not returned to the manufacturer.
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As reported: "patient's left tibial component was revised due to loosening¿all tibial components (12x50 stem, size 3 universal baseplate, two augments, 3x16 ts insert)¿were explanted and revised to triathlon ts.Tibial side as a whole was loosened, no specific implant(s) cited.".
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