STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR; 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 Problem
Inadequate Osseointegration (2646)
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Event Date 11/26/2020 |
Event Type
Injury
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Manufacturer Narrative
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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 implant prescription form was received for the patient's left patient specific device with note: "loosening of tibia component.Please provide a tibial component only which is 2 cm longer than current implant in situ.Will also need new buses, axle and bumper please".
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Manufacturer Narrative
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Reported event: an event regarding loosening involving a patient specific, distal femur, 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 distal femoral replacement which was inserted on (b)(6) 1989.The surgeon reported aseptic loosening of the tibial stem.The x-ray images provided show radiolucent lines along the stem between the cement mantle and stem and between the cement mantle and bone.There are massive bone remodelling and lesion at the tip of the stem, in which the tip of the stem has tilted lateral-posteriorly.Therefore, the radiographic review can confirm the clinical report and reason for revision.Device history review: review of siw records indicate the device was inserted on (b)(6) 1989.Complaint history review: there have been no other relevant 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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Event Description
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A patient specific implant prescription form was received for the patient's left patient specific device with note: "loosening of tibia component [.] please provide a tibial component only which is 2cm longer than current implant in situ.Will also need new buses, axle and bumper please".
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