STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG) - FEMORAL STEM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number UNK_STM |
Device Problems
Unstable (1667); Loss of Osseointegration (2408)
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Patient Problems
Inadequate Osseointegration (2646); Joint Laxity (4526)
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Event Date 08/01/2022 |
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.
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Event Description
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A patient specific prescription form has been received.Noted on the form " revision of extended implant.Previous grower well fixed proximal stem.Extra small femur to cement over current stem to create definitive implant.Also need an extra small metal cased rotation hinge tibial component please.Previous osteosarcoma now unstable implant.".
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Manufacturer Narrative
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Reported event: an event regarding loosening involving a mig, distal femoral replacement, femoral 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: the implant in situ was for mig distal femoral replacement, in which the original implant was inserted on (b)(6) 1999 and subsequently revised several times.The surgeon reported unstable implant.The ct image provided shows radiolucent lines along the femoral and tibial stems mainly between the cement mantle and stem.Especially for tibial stem, aseptic loosening of the stem can be expected which may explain unstable implant.Therefore, the radiographic review can confirm the clinical report and reason for revision.Device history review: review of the product history records indicate the device was manufactured and accepted into final stock 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 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 prescription form has been received.Noted on the form " revision of extended implant.Previous grower well fixed proximal stem.Extra small femur to cement over current stem to create definitive implant.Also need an extra small metal cased rotation hinge tibial component please.Previous osteosarcoma now unstable implant." update 28 oct 2022: clinical review confirms the following: " [.] the ct image provided shows radiolucent lines along the femoral and tibial stems mainly between the cement mantle and stem.Especially for tibial stem, aseptic loosening of the stem can be expected which may be explain unstable implant [.]".This mdr is for the femoral stem.
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