STANMORE IMPLANTS WORLDWIDE PROXIMAL TIBIA; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number UNK_STM |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Inadequate Osseointegration (2646); Cancer (3262)
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Event Date 12/16/2020 |
Event Type
Injury
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Manufacturer Narrative
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The reported device is similar to a device approved for compassionate use in the united states.It was noted that the device is not available for evaluation.Should additional information become available, 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 relevant reported discrepancies.There have been no other similar events for the lot referenced.Device not returned.
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Event Description
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A patient specific prescription form was received for the patient's left proximal tibia.Reason for surgery indicates: "ewing sarcoma last revised 1996" and reason for revision indicates: "aseptic loosening." form also indicates "full revision.Rotating hinge.Ha collar.".
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Event Description
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A patient specific prescription form was received for the patient's left proximal tibia.Reason for surgery indicates: "ewing sarcoma last revised 1996" and reason for revision indicates: "aseptic loosening." form also indicates "full revision, rotating hinge, ha collar.".
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Manufacturer Narrative
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Reported event: an event regarding loosening involving a patient specific, proximal tibia, tibial stem was reported.The event was confirmed by x ray review.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided x-rays by a clinical consultant indicated: the implant in situ was for a proximal tibial replacement which was inserted on (b)(6) 1996.The surgeon reported an aseptic loosening of the stem.The image provided shows massive radiolucent lines along the stem between the cement mantle and cortical bone.There are significant bone resorption and osteolytic lesion which left a thin cortex in general.Therefore, the radiographic review can confirm the clinical report and reason for revision.Device history review: review of the product history records indicate (b)(4) device was manufactured and accepted into final stock on 08 oct 1996 with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, pathology 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.
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