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This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) [summary of retrospective data for patients treated with the lateral femoral nail, adolescent lateral femoral nail, and the femoral recon nail].Between january 2014 and october 2021, a total of 300 patients (219 patients treated with lfn, 56 patients treated with alfn, and 25 patients treated with frn) were included in the report if they had either 9 months of follow-up or evidence of healing.The following complications have been identified in the (b)(6) hospital¿s orthopedic inpatient database: lfn group: (b)(6): a 32-year-old male patient had a weakness in leg, which resolved with physical therapy.(b)(6): : an 81-year-old male patient had a persistent swelling about knee 1.5 years postoperatively, compression.(b)(6): a 58-year-old female patient had a pulmonary embolism.(b)(6): a 35-year-old female patient had difficult reduction intraoperatively and had residual soreness at incision site postoperatively.(b)(6): a 16-year-old male patient had pain with implants leading to rehospitalization for adjunctive plate removal, lfn was not revised (b)(6): a 25-year-old male patient had difficult reduction intraoperatively.(b)(6): a 67-year-old male patient had weakness, delayed return to work and went on disability secondary to impending retirement.(b)(6): a 27-year-old male patient had infection and was rehospitalized for incision and drainage at 1.5months; superficial infection from mvc wounds.(b)(6): a 55-year-old male patient had prominent screw and was rehospitalized for hardware removal of distal interlock at 6 months.(b)(6): a 67-year-old female patient had difficult reduction intraoperatively.(b)(6): a 29-year-old male patient had slow rehabilitation/ambulation and mobility limited secondary to calcaneus fracture.(b)(6): a 20-year-old male patient had knee effusion post operatively and continued knee effusion, mri negative and resolved at 3 months.(b)(6): a 54-year-old male patient had delayed pt/strengthening secondary to spinal injury; spinal injury limiting recovery of femur (rom and strengthening).(b)(6): a 62-year-old female patient was rehospitalized for adjunctive hardware removal of condylar plate at 8 months.(b)(6): a 42-year-old male patient had amputation, revision amputation (bka) secondary to trauma and was rehospitalized for orif pilon from same trauma at 0.75 months and extended follow up secondary to multiple injuries.(b)(6): : a 24-year-old male patient had difficult airway and ventilation issues d/t traumatic injury, remained vented following surgery per trauma.(b)(6): a 28-year-old male patient was rehospitalized for heterotopic ossification removal at 12 months.(b)(6): a 50-year-old male patient had difficult reduction intraoperatively.(b)(6): a 21-year-old female patient was rehospitalized for knee arthroscopy, lysis of adhesion at 5 months and knee adhesion on ipsilateral side of implant.(b)(6): a 18-year-old male patient had delayed wound healing.(b)(6): a 31-year-old male patient had decreased strength, wound healing delay.(b)(6): a 54-year-old male patient had extensive washout of open wound, difficult reduction intraoperatively; was rehospitalized and revised for hardware removal due to infection/ osteomyelitis, subsequent bka at 5 months.(b)(6): a 23-year-old male patient had wound infection, delayed wound healing and superficial infection, solved with abx only.(b)(6): a 16-year-old male patient had difficult airway and icu following surgery, delayed recovery secondary to polytrauma.(b)(6): a 30-year-old male patient had high estimated blood loss and difficult reduction intraoperatively; transfuse 1unit prbc.(b)(6): a 23-year-old male patient had intraoperative small fat emboli r/t polytrauma.(b)(6): a 57-year-old female patient had pulmonary embolism and treated medically and recovered well.(b)(6): a 54-year-old male patient fell with fracture distal to im nail and was rehospitalized requiring retrograde imn.(b)(6): a 22-year-old male patient had 1cm leg length discrepancy per leg length films (longer on operative side).No rotational deformities noted.Highly comminuted fracture for the femoral shaft; transitioned to vocational training as unable to return to previous manual labor.(b)(6): a 29-year-old male patient had not returned to work proceeding with ankle arthrodesis for post-traumatic arthrosis.(b)(6): a 32-year-old male patient had heterotopic ossification following open femoral shaft injury with associated head injury; polytrauma with extensive tbi and limited functional recovery cognitively.(b)(6): 20-year-old male patient did not achieve radiological union; 24 weeks progressing to union with bridging callous on ap and lateral but lucency remaining visible.(b)(6): a 21-year-old male patient had nonunion, was rehospitalized and revised for nonunion repair; lfn removed at 6 months, replaced with non-dps nail.(b)(6): a 64-year-old male patient had 1cm leg length discrepancy per leg, no intervention.Patient 202: a 41-year-old female patient had longer f/w for hip pain, bursitis- resolved with conservative.Alfn group: (b)(6): a 13-year-old female patient was rehospitalized for screw removal due to broken distal interlock.(b)(6): a 40-year-old male patient had pain at distal interlock; was rehospitalized for screw removal due to pain.(b)(6): a 13-year-old male patient had limited knee rom, extension to 100 degrees flexion; continued pt recovered full knee rom (b)(6): an 18-year-old male patient had weakness, continued pt resolution.(b)(6): a10-year-old male patient had prominent hardware/loosening screw distally; was rehospitalized for hardware removal d/t family not wanting child to have metal in body long term.(b)(6): an 18-year-old male had prominent hardware or patient discomfort/loosening screw distally; was rehospitalized for hardware removal.(b)(6): a 12-year-old male patient had persistent pain but cancelled hardware removal surgery, no further follow up.(b)(6): a 17-year-old male patient had difficult reduction intraoperatively; fracture instability/shortening postoperatively; was rehospitalized for revision surgery due to fracture shortening, broken screw; largely comminuted fracture.Frn group: (b)(6): a 42-year-old male patient had delayed union secondary to gsw.(b)(6): a 26-year-old male patient had difficult reduction intraoperatively; distal screw loosening postoperatively; segmental femur fracture.(b)(6): a 28-year-old female patient had limited strength; postoperative weakness resolved with pt.(b)(6): a 28-year-old male patient had limited strength secondary to associated spinal injury.(b)(6): a 23-year-old male patient had antalgic gait resolved with pt for 3 months.(b)(6): a 48-year-old male patient had persistent pain postoperatively.(b)(6): a 28-year-old male patient had rehabilitation extended to 8 months, full mobility and strength regained.(b)(6): a 44-year-old male patient had difficult reduction intraoperatively; severely comminuted, unicortical plate used for reduction.(b)(6): a 32-year-old male patient had postoperative infection treated with abx.(b)(6): a 26-year-old male had a gun shot wound causing femoral artery injury and grafting.This report is for a 23-year-old male patient had antalgic gait resolved with pt for 3 months.This is report 10 of 14 for (b)(4).Additional devices are captured on related complaints (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.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes employee device evaluated by mfr: 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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