Catalog Number UNK_STM |
Device Problems
Material Deformation (2976); Insufficient Information (3190)
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Patient Problems
Failure of Implant (1924); Injury (2348); Cancer (3262)
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Event Date 12/12/2018 |
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 to the manufacturer.
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Event Description
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A patient specific implant prescription was received for patient's left tibia with diagnosis "osteosarcoma" and additional notes "revision tibial (xxx) to adult type metal bushed tibia.No plan to revise femur.Required by date is 4-6 weeks.
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Event Description
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A patient specific implant prescription was received for patient's left tibia with diagnosis "osteosarcoma" and additional notes "revision tibial (xxx) to adult type metal bushed tibia.No plan to revise femur.Required by date is 4-6 weeks.Update (b)(6) 2019 - this patient was involved in an rta and the tibial component has bent/warped within the bone.
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Manufacturer Narrative
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Additional manufacturer narrative - an event regarding an alleged bent/warped tibial stem following a road traffic accident involving a jts distal femur replacement was reported.The event was confirmed by medical review.Method and results: product evaluation and results: visual inspection: not performed as no items were returned.Dimensional inspection : not performed as no items were returned.Functional inspection: not performed as no items were returned.Material analysis: not performed as no items were returned.Clinician review: the implant in situ was for a non invasive jts distal femoral replacement which was inserted on: (b)(6)2007.The images show that the tibial stem was bent posteriorly in the midshaft and the posterior cortex is very thin indicating that an extraordinary force has passed to the tibial stem.On the other hand, the jts distal femur has been extended by 50mm which has reached to its intended maximum capacity of 50mm.The above observations confirm the reason for revision.Product history review: review of the product history records indicate (b)(4) device was manufactured and accepted into final stock on 16may2007 with no reported discrepancies.Complaint history review: there have been no other events.Conclusions: the investigation concluded that the alleged damage was caused by an extraordinary force applied to the tibial stem resulting in the stem becoming warped/bent.It is reported that the patient was involved in a road traffic accident.No further investigation for this event is possible at this time as no devices were received by siw.If devices and additional information become available to indicate further evaluation is warranted, this record will be re-opened.Siw will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.
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Search Alerts/Recalls
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