STANMORE IMPLANTS WORLDWIDE MIDSHAFT TIBIA - TIBIAL COMPONENT LUG; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number UNK_STM |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/31/2022 |
Event Type
Injury
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Event Description
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A patient specific implant request form was received for revision of the patient's right tibial diaphyseal replacement.Noted on the form: "screws for siw modular tibial diaphyseal replacement.The proximal connecting screw has broken and requires screw replacement." update 12sep2022: additional information provided: "there is a tibial diaphyseal replacement in situ.The proximal connecting screw has broken and requires screw replacement." update: 28nov22 clinical review confirmed the following: " the ct image provided shows that the distal screw together with the lug were broken, which lead to disengagement of the diaphyseal assembly".
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Manufacturer Narrative
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Reported event: an event regarding crack/fracture involving a patient specific, midshaft tibia, tibial component 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 patient specific midshaft tibial replacement which was inserted on (b)(6) 2018.The surgeon reported a broken screw for diaphyseal assembly.The ct image provided shows that the distal screw together with the lug were broken, which lead to disengagement of the diaphyseal assembly.Therefore, the radiographic review can confirm the clinical report and reason for revision.Device history review: review of the product history records indicate devices 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, 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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