MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HIP SCR Ø6.5 SELF-TAP L100 F/EXPERT LFN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.003.030

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pulmonary Embolism (1498)

Event Type  Injury  

Event Description

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: patient 5: a 32-year-old male patient had a weakness in leg, which resolved with physical therapy.Patient 6: an 81-year-old male patient had a persistent swelling about knee 1.5 years postoperatively, compression.Patient 8: a 58-year-old female patient had a pulmonary embolism.Patient 9: a 35-year-old female patient had difficult reduction intraoperatively and had residual soreness at incision site postoperatively.Patient 13: a 16-year-old male patient had pain with implants leading to rehospitalization for adjunctive plate removal, lfn was not revised patient 17: a 25-year-old male patient had difficult reduction intraoperatively.Patient 18: a 67-year-old male patient had weakness, delayed return to work and went on disability secondary to impending retirement.Patient 20: a 27-year-old male patient had infection and was rehospitalized for incision and drainage at 1.5months; superficial infection from mvc wounds.Patient 22: a 55-year-old male patient had prominent screw and was rehospitalized for hardware removal of distal interlock at 6 months.Patient 23: a 67-year-old female patient had difficult reduction intraoperatively.Patient 24: a 29-year-old male patient had slow rehabilitation/ambulation and mobility limited secondary to calcaneus fracture.Patient 28: a 20-year-old male patient had knee effusion post operatively and continued knee effusion, mri negative and resolved at 3 months.Patient 30: a 54-year-old male patient had delayed pt/strengthening secondary to spinal injury; spinal injury limiting recovery of femur (rom and strengthening).Patient 35: a 62-year-old female patient was rehospitalized for adjunctive hardware removal of condylar plate at 8 months.Patient 40: 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.Patient 44: a 24-year-old male patient had difficult airway and ventilation issues d/t traumatic injury, remained vented following surgery per trauma.Patient 45: a 28-year-old male patient was rehospitalized for heterotopic ossification removal at 12 months.Patient 60: a 50-year-old male patient had difficult reduction intraoperatively.Patient 64: 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.Patient 69: a 18-year-old male patient had delayed wound healing.Patient 72: a 31-year-old male patient had decreased strength, wound healing delay.Patient 74: 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.Patient 85: a 23-year-old male patient had wound infection, delayed wound healing and superficial infection, solved with abx only.Patient 91: a 16-year-old male patient had difficult airway and icu following surgery, delayed recovery secondary to polytrauma.Patient 93: a 30-year-old male patient had high estimated blood loss and difficult reduction intraoperatively; transfuse 1unit prbc.Patient 103: a 23-year-old male patient had intraoperative small fat emboli r/t polytrauma.Patient 110: a 57-year-old female patient had pulmonary embolism and treated medically and recovered well.Patient 122: a 54-year-old male patient fell with fracture distal to im nail and was rehospitalized requiring retrograde imn.Patient 123: 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.Patient 134: a 29-year-old male patient had not returned to work proceeding with ankle arthrodesis for post-traumatic arthrosis.Patient 138: 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.Patient 153: 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.Patient 187: 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.Patient 198: 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: patient 3: a 13-year-old female patient was rehospitalized for screw removal due to broken distal interlock.Patient 14: a 40-year-old male patient had pain at distal interlock; was rehospitalized for screw removal due to pain.Patient 27: a 13-year-old male patient had limited knee rom, extension to 100 degrees flexion; continued pt recovered full knee rom patient 30: an 18-year-old male patient had weakness, continued pt resolution.Patient 38: 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.Patient 39: an 18-year-old male had prominent hardware or patient discomfort/loosening screw distally; was rehospitalized for hardware removal.Patient 43: a 12-year-old male patient had persistent pain but cancelled hardware removal surgery, no further follow up.Patient 44: 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: patient 2: a 42-year-old male patient had delayed union secondary to gsw.Patient 3: a 26-year-old male patient had difficult reduction intraoperatively; distal screw loosening postoperatively; segmental femur fracture.Patient 6: a 28-year-old female patient had limited strength; postoperative weakness resolved with pt.Patient 9: a 28-year-old male patient had limited strength secondary to associated spinal injury.Patient 10: a 23-year-old male patient had antalgic gait resolved with pt for 3 months.Patient 12: a 48-year-old male patient had persistent pain postoperatively.Patient 15: a 28-year-old male patient had rehabilitation extended to 8 months, full mobility and strength regained.Patient 16: a 44-year-old male patient had difficult reduction intraoperatively; severely comminuted, unicortical plate used for reduction.Patient 20: a 32-year-old male patient had postoperative infection treated with abx.Patient 24: a 26-year-old male had a gun shot wound causing femoral artery injury and grafting.This report is for (lfn group) patient 110: a 57-year-old female patient had pulmonary embolism and treated medically and recovered well.This is report 15 of 15 for (b)(4).Additional devices are captured on related complaints (b)(4).

Manufacturer Narrative

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.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes employee.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.

• Brand Name: HIP SCR Ø6.5 SELF-TAP L100 F/EXPERT LFN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15075151
• MDR Text Key: 296310773
• Report Number: 2939274-2022-02790
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.003.030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female