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Additional device product codes: hrs, hwc.Reporter is attorney.Complainant part is not expected to be returned for manufacturer review / investigation.(b)(4).Without a lot number the device history records review could not be completed.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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It was reported that initially on (b)(6) 2018, the patient underwent an open reduction and internal fixation of the left femur due to a comminuted fracture of the midshaft.The patient has a boot on the right leg for another orthopedic issue in which the velcro of the boot got stuck on the recliner handle causing her to fall twisting her left leg.The patient had pain and inability to ambulate afterward and was brought to the emergency department.The fracture was stabilized using (1) 4.5mm variable angle- locking compression plate curved condylar plate 16 holes, left, 336mm, (6) synthes 1.7mm cerclage cables and (12) synthes screws.She tolerated the procedure well, was awakened, transferred to the recovery room in good condition.The patient was then taken to a skilled nursing facility after discharge where she spent 2 and half months completing inpatient rehab.Afterward, she was released to home where she then spent another month working with a home health physical therapist (2 times per week) and later was asked to progress to outpatient therapy.She has been doing well in her recovery with increasing mobility and with no pain in the left thigh.Radiographs performed on (b)(6) 2019, demonstrated the hardware in a good position and fracture well aligned.On (b)(6) 2019, the patient sought to consult due to pain and difficulty walking.The pain was described as sharp, aching, soreness continuously aggravated by certain movements like walking and weight-bearing.The pain score was 10/10.3 days prior to the consultation, the patient jammed her leg into a glass top coffee table.She did not think much of it then the following day, she was doing exercises and had severe pain when she tried to walk afterward.X-rays on the same day demonstrated a failure of hardware with a broken plate with all of the screws proximally and distally and all of the cables intact.On (b)(6) 2019, the patient underwent removal of one (1) 4.5mm variable angle- locking compression plate curved condylar plate 16 holes, left, 336mm, six (6) 1.7mm cerclage cables and twelve (12) screws and revision open reduction and internal fixation of midshaft left femur due to hardware failure and nonunion.During the operation, the fracture and hardware noted to be markedly comminuted and displaced.The majority of the fracture seemed to have healed but the transverse fracture had not healed.The patient tolerated the procedure well, was awakened, and transferred to the recovery room in good condition.Concomitant devices reported: 5.0mm variable angle locking screw 70mm (part number: 02.231.270, lot number: unknown, quantity: 3) 5.0mm variable angle locking screw 46mm (part number: 02.231.246, lot number: unknown, quantity: 1) 1.7mm cocr cable with ti crimp 750mm-sterile (part number: 611.105.01s, lot number: p307701, quantity: 2) 1.7mm cocr cable with ti crimp 750mm-sterile (part number: 611.105.01s, lot number: p177539, quantity: 2) 1.7mm cocr cable with ti crimp 750mm-sterile (part number: 611.105.01s, lot number: p177263, quantity: 1) 5.0mm variable angle locking screw 42mm (part number: 02.231.242, lot number: unknown, quantity: 3) 1.7mm cable with crimp 750mm-sterile (part number: 298.801.01s, lot number: unknown, quantity: 2) 5.0mm variable angle locking screw 32mm (part number: 02.231.232, lot number: unknown, quantity: 1) 5.0mm variable angle locking screw 40mm (part number: 02.231.240, lot number: unknown, quantity: 1) 5.0mm variable angle lockng screw 75mm (part number: 02.231.275, lot number: unknown, quantity: 2) unknown, quantity: 1).This report is for one (1) 4.5mm va-lcp curved condylar plate/16 hole/336mm/left.This is report 1 of 1 for complaint (b)(4).
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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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.B7 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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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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b7; d6a; d6b.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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