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It was reported that a patient was pumping gas and stepped over gas pump hose when he tripped and fell onto his left side and injured his left hip on (b)(6) 2014.Patient reported that he straightened his left leg and heard a pop and some pain.The patient reported having some recurrent sciatica symptoms with his right hip and knee and his knee would periodically give out.Patient believes his right leg may have buckled, causing the fall/fracture of his left lower extremity.Patient had severe pain and was unable to ambulate thereafter.His right leg had some contusions following the fall.It was noted that his left lower extremity was in external rotation.Patient underwent open reduction internal fixation for a left subtrochanteric femur fracture on (b)(6) 2014.There was oozing from fracture site which required intraoperative transfusion with 5 units of packed red blood cells.The 9-hour surgery was complicated and prolonged including one hour of transfusion.Estimated blood loss during surgery was approximately 2 liters.Preliminary x-rays taken on (b)(6) 2014 of the left hip showed severe posterior sag of the proximal segment and anterior thigh.To help reduce the posterior sag deformity, a crutch was placed and pressure on the anterior thigh to help reduce apex anterior angulation of the distal femur allowed closer alignment of the fracture.Appropriate reduction maneuvers were then used to try and place the short oblique fracture site into a better reduction position.Due to the continued pull of the iliopsoas, no anatomic reduction could be achieved and so the skin over the fracture site was then incised.There was failure to achieve appropriate rotation at the fracture site due to the short oblique fracture pattern and the medial and posterior bone loss.There was varus angulation at the fracture site due to the nature of the fracture pattern.Manual reduction as well as clamps were then performed at the fracture site to obtain a near anatomic reduction and then proximal and subsequent serial reaming was then done.A nail (non-synthes) was placed from proximal to distal, and there was significant displacement and malrotation at the fracture site.Nail was removed and re-reduction done.With an attempt at a pass from the proximal to distal fracture site, no anatomic reduction could be maintained.It was also noted that the patient was moving his leg and so the anesthesiologist performed an awake intubation on the patient.Assistance from another surgeon was obtained to manage the fracture site to achieve a near anatomic reduction, and safely place instrumentation.The nail was passed from proximal to distal and there was still malrotation, diastasis and angulation at the fracture site.A recon plate was then placed at the anterior aspect of the femur bridging the fracture site once the fracture was in near anatomic position.This helped to reduce the fracture site and the nail was attempted to be placed again.It was believed that the nail would continue to cause a fracture diastasis and malrotation even with an anterior plate for added stability.The gamma nail which could not be placed was removed and a proximal femoral locking plate was used to achieve and hold near anatomic reduction and rotation.This plate was called for and there was none available and a large fragment broad plate, the longest one in the set, was used and positioned to maximize proximal fixation.An 11-hole plate was used and at least 6 cortices were achieved proximally and greater than 8 cortices were achieved distally.(large fragment broad plate, 11 hole and recon plate, 6-hole with corresponding non locking cortical and cancellous screws) (2 large fragment plates with 1 lateral and 1 anterior).The entire construct consisted of plates and screws from another manufacturer, with the exception of one 4.5mm cortex screw.According to the implant records the synthes screw was documented along with the other manufacturer¿s screw.It is unknown as to which screw was implanted in the patient.The implant records documented both screws.The anterior plate was removed and a longer 6-hole plate (non-synthes) was placed to achieve bicortical fixation of this anterior plate, placed in a 90-degree position from large frag plate.Anterior large fragment plate was not able to be fit.Wound was then thoroughly irrigated.A 30 ml bottle of cancellous bone chips were then used to fill the posterior medial and proximal defects from the initial injury.Wound was then thoroughly irrigated.Patient was closed and left lower extremity was then placed in a knee immobilizer.Patient was stable and transferred to the recovery.Sepsis screening was completed on (b)(6) 2014 and no clinical suspicion of infection was currently present.On (b)(6) 2014 it was noted that the thigh and buttock was swollen with reports of pain with moderate pressure.Iv antibiotics were continued 24 hours from day of surgery, due to prolonged intraoperative open wound exposure.On (b)(6) 2014 it was noted that patient has numbness in right foot and pain around fracture site.Decreased sensation still at the plantar aspect of the foot and at the first webspace.Patient transfused with another unit of packed red blood cells on (b)(6) 2014.On (b)(6) 2014 it was noted that the incision is clean, dry, and intact, but there is obvious serous drainage onto the dressings.Pain reported in the knee, left hip and right calf pain that was worse with foot flexion reported on (b)(6) 2014.Patient noted to have plate fixation with some varus collapse but no acute signs of infection other than mild erythema of the wound.Postoperatively, patient was transferred to a local skilled nursing facility for 2 days and then subsequently transferred on (b)(6) 2014 to another skilled nursing center for approximately 2 weeks.Status post 4 weeks ((b)(6) 2014), patient still complaining of pain in left hip.The left hip joint is intact.There is a proximal femur fracture with recent orif and no displacement.Staples removed on (b)(6) 2014 from left hip and steri strips applied.Given an immobilizer on (b)(6) 2014.Small amounts of serous drainage noted.Surgical incision warm to touch, redness noted around staples insertion site.Pain in hip noted on (b)(6) 2014.Mild erythema was noted around the staple sites with drainage, subsequently resolved.There was minimal pain and able to participate in physical therapy.Drainage resolved completely for 3-4 days, after being discharged on (b)(6) 2014.Patient at home for approximately 3 days when he noted the onset of large amounts of discharge from his left hip incision.He was seen in the office, where his left hip incision was erythematous, indurated with serous discharge issuing from the incision site and he was admitted for evaluation of possible postoperative hip infection.Patient was admitted on (b)(6) 2014 with the presumptive diagnosis of postoperative left hip infection.He was started on vancomycin after cultures of the discharge and blood cultures were obtained.Cat scan of the left hip revealed a subacute fracture of the left proximal femur just below the femoral neck with mild angulation.Fracture was mildly comminuted.There was a lateral plate and screw fixation device in place traversing the fracture.There was diffuse soft tissue edema within the thigh proximally and laterally.There was overlying mild skin thickening and multiple small foci of subcutaneous emphysema in the proximal thigh.There were prominent left inguinal lymph nodes.Wound culture subsequently returned heavy staph aureus, methicillin-sensitive.Patient taken to the or with findings of extensive infection, finding significant amounts of purulent fluid for the entire length of the incision down to the bone.This tracked to the femur, with noted large amounts of purulent material throughout the entire area.Bone grafts, bone chips that were placed on the original surgery were identified and much of this was removed as possible.Irrigation of the area was done and significant debridement of as much of the bone graft was performed.After lavage and debridement the patient was closed and tolerated the surgery well.In view of the infection and need for further hardware revision, it was felt that the patient would benefit from transfer to another hospital for further orthopedic care.Additionally, during his hospital course, when he was admitted, his bun and creatinine were slightly elevated and this was addressed with iv fluid rehydration.He also had some elevated liver function tests on admission and this was felt perhaps to be fatty infiltration or perhaps due to lipitor or perhaps due to inflammation associated with his postoperative hip infection.An abdominal ultrasound showed fatty liver infiltration.He also was noted to develop progressive anemia during his hospitalization and felt to be postoperative blood loss, and he was transfused 2 units of packed cells and on day of transfer.His left lower leg edema was addressed with a left leg ultrasound showing no evidence of deep venous thrombosis.The left lower extremity revealed an edematous left leg with 2+ ankle edema.There was a long lateral left hip incision with erythema surrounding the entire incision, with induration surrounding the incision and expression of clear serous fluid can be expressed by pressing along the edges of the wound.In the inferior portion of this, there is oozing with an expressible thin, yellow discharge.There is erythema surrounding the inferior portion of the wound.Distally, he has more pitting edema.Examination of the left lower extremity reveals diffuse swelling of the left ankle and foot.Examination of the wound reveals furthering erythema around the wound with a large amount of pink/white colored drainage from a dehiscence that is approximately 0.5 cm near the inferior pole of the wound.Patient is status post orif of hip with infection.Postoperative wound infection (b)(6) infection noted on (b)(6) 2014 and osteomyelitis of the left hip and femur.Irrigation, debridement of left hip and femur with obtaining cultures closure over a hemovac with closure with incisional wound vac on (b)(6) 2014.Imaging of left femur (b)(6) 2014 demonstrating lateral plate fixation with failure but no breakage, with significant varus deformity at the subtrochanteric femur and displacement of the lesser trochanter, concerning for underlying reverse obliquity intertrochanteric component.The same skin incision was made on (b)(6) 2014 and a significant amount of purulent fluid egressed from the incision site for the entire length of the incision down to bone.There was a clear and distinct plane that was tracked all the way to the femur itself.It was noted to be a large amount of purulence throughout this entire area.There was noted be cancellous bone chips allograft that had been described being placed during the index procedure by the outside surgeon.Cancellous bone chips allograft was removed.Irrigation and debridement of the bone graft that was visible was performed and there was also noted to the purulent tissue that was adherent to the plate, which was also debrided.During this procedure, fluoroscopy was taken to see if there was any change in hardware position.There was slight fall of the fracture fragments into more varus from the initial x-rays from the prior week.There was noted to be movement of the fracture with the fixation in place.The area was irrigated and a hemovac drain was placed and the surgical site was closed.Last drain was discontinued (b)(6) 2014 and had a wound vac placed over the incision until (b)(6) 2014.Rectal abscess incision and drainage.Patient discharged on (b)(6) 2014.This event is captured in three (3) complaint files: (b)(4) captures the legacy complaint (b)(4) - patient underwent open reduction internal fixation for a left subtrochanteric femur fracture on (b)(6) 2014.(b)(4) captures postoperative infection and irrigation and debridement on (b)(6) 2014.(b)(4) captures postoperative infection and removal of hardware on (b)(6) 2014.This report is for one (1) 4.5mm cortex screw self-tapping 60mm.This is report 1 of 1 for (b)(4).
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Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Customer quality conducted a review of the provided x-rays.Ct images provided were reviewed and the complaint condition of infection cannot be confirmed based on images, therefore further investigation cannot be performed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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