STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR JTS - TIBIAL STEM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number UNK_STM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 06/19/2022 |
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 prescription form has been received "fracture and growth arrest of tibial component (passive slider) beneath non invasive proximal femoral grower.Right side." notes on prescription form: fracture at tibial stem after medial growth arrest (b)(6) 2022.Fracture now healed in malunion.
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Manufacturer Narrative
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Reported event: an event regarding periprosthetic fracture involving a jts, distal femoral replacement, 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 jts distal femoral replacement which was inserted on (b)(6)2019.The surgeon reported periprosthetic fracture around the tibial stem and medial growth arrest.The x-ray images provided show a spiral tibial bone fracture near the distal tibial stem.The tibial plateau has deformed and tilted towards medial and posterior.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 "fracture and growth arrest of tibial component (passive slider) beneath non invasive proximal femoral grower.Right side." notes on prescription form - fracture at tibial stem after medial growth arrest (b)(6) 2022.Fracture now healed in malunion.
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