STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR JTS - TIBIAL COMPONENT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number UNK_STM |
Device Problem
Unintended Movement (3026)
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Patient Problems
Ambulation Difficulties (2544); Unequal Limb Length (4534)
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Event Date 04/25/2022 |
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 implant prescription form was received for the patient's left distal femur jts.Noted on the form: "leg length discrepancy, terminally extended jts in place.Will leave femoral stem in place.Tibia will require revision." 03may22 update "the proximal tibia is not growing and i think that it has subsided.If it is well fixed, then will leave in situ.If it is not well fixed will revise.Happy to go to an adult style if it will marry to the jts".
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Event Description
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A patient specific implant prescription form was received for the patient's left distal femur jts.Noted on the form: "leg length discrepancy, terminally extended jts in place.Will leave femoral stem in place.Tibia will require revision." 03may22 update "the proximal tibia is not growing and i think that it has subsided.If it is well fixed, then will leave in situ.If it is not well fixed will revise.Happy to go to an adult style if it will marry to the jts".
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Manufacturer Narrative
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Reported event: an event regarding a jts, distal femoral replacement, tibial component was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the subject device was not returned and no photographs were provided for review.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) 2017.The surgeon reported leg length discrepancy and proximal tibia not growing.The x-ray image provided shows that the implant has been extended by 50mm which reached its maximum capacity of 50mm.The length of the affected leg is about 706cm which is similar to the opposite leg.However, the length of the affected tibia is 294cm which is shorter than the opposite tibia (308cm).In addition, the affected tibial epiphyseal area has deformed which affected the tibial grow.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 relevant events for the lot referenced.Conclusion: the clinical review confirmed the reason for revision as limb length discrepancy and states: "the affected tibial epiphyseal area has deformed which affected the tibial grow".However the reported subsidence event can not be confirmed.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports and progress notes 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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