It was reported that after implantation of a right stryker hip and competitor knee, the patient fell and sustained a femoral fracture near the distal tip of the stem.No implants were revised, but an orif was performed with implantation of a plate and screws.Rep confirmed that no further information will be released by the hospital or surgeon.
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Reported event:: an event regarding periprosthetic fracture involving an omnifit stem was reported.The event was confirmed through clinician review of the provided medical records.Method & results: product evaluation and results: visual inspection, material analysis, dimensional and functional inspections were not performed as the device remained implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated " this patient ostensibly had a well-functioning right cementless total hip arthroplasty but then sustained a fracture of the femur below the tip of the stem.The patient already had a competitor total knee arthroplasty in place.An open reduction and internal fixation was carried out but this resulted in a nonunion with breakage of screws and pull away of the plate.The patient subsequently required a total femoral replacement and then sustained a dislocation of the hip which required insertion of a constrained liner.I can confirm that the patient had a primary right total hip arthroplasty and prior surgery with plate and screws which appears to be for a mid-shaft femoral fracture below the tip of the stem.I have only a single x-ray showing what i described.I have no documentation of further procedures regarding x-rays, office notes or operation notes.Causes of these events are multifactorial and the root causes cannot be determined with certainty.The patient did sustain a fall which resulted in a fracture of the femoral shaft below the tip of the stem.This would definitely be the cause of the fracture itself.Failure of fixation is multifactorial including surgical technique, patient bone quality issues, patient activity level and bmi.Screw breakage is not uncommon when internal fixation fails and in my opinion is not necessarily the fault of the screw but rather the technique of fixation and stability of the fracture.The cause of nonunion is also multifactorial including surgical technique, local bone factors and postoperative compliance with weight bearing, etc.I have no x-rays which would allow me to comment on the need for a total femoral prosthesis.The causes of dislocation a few days following hip arthroplasty are almost always iatrogenic meaning that there was most likely failure to restore the proper soft tissue tension to the thigh muscles and possibly impingement may have occurred.Without x-rays or other diagnostic tools, i cannot comment on the root cause of the dislocation with certainty.Product history review: review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been 1 other similar event for the lot referenced that relates to periprosthetic fracture for the same device/patient; therefore, no further trending is required for this commonality.Conclusions: a review of the provided medical records by a clinical consultant indicated " this patient ostensibly had a well-functioning right cementless total hip arthroplasty but then sustained a fracture of the femur below the tip of the stem.The patient already had a competitor total knee arthroplasty in place.An open reduction and internal fixation was carried out but this resulted in a nonunion with breakage of screws and pull away of the plate.The patient subsequently required a total femoral replacement and then sustained a dislocation of the hip which required insertion of a constrained liner.I can confirm that the patient had a primary right total hip arthroplasty and prior surgery with plate and screws which appears to be for a mid-shaft femoral fracture below the tip of the stem.I have only a single x-ray showing what i described.I have no documentation of further procedures regarding x-rays, office notes or operation notes.Causes of these events are multifactorial and the root causes cannot be determined with certainty.The patient did sustain a fall which resulted in a fracture of the femoral shaft below the tip of the stem.This would definitely be the cause of the fracture itself.Failure of fixation is multifactorial including surgical technique, patient bone quality issues, patient activity level and bmi.Screw breakage is not uncommon when internal fixation fails and in my opinion is not necessarily the fault of the screw but rather the technique of fixation and stability of the fracture.The cause of nonunion is also multifactorial including surgical technique, local bone factors and postoperative compliance with weight bearing, etc.I have no x-rays which would allow me to comment on the need for a total femoral prosthesis.The causes of dislocation a few days following hip arthroplasty are almost always iatrogenic meaning that there was most likely failure to restore the proper soft tissue tension to the thigh muscles and possibly impingement may have occurred.Without x-rays or other diagnostic tools, i cannot comment on the root cause of the dislocation with certainty.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.H3 other text : device not returned.
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