MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: LCP LISS-DF; PLATE, FIXATION ,BONE

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

Patient Problems Fistula (1862); Unspecified Infection (1930); Non-union Bone Fracture (2369)

Event Type  Injury  

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.This report is for an unknown constructs: lcp liss-df/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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.

Event Description

Device report from synthes reports an event in switzerland as follows: this report is being filed after the review of the following journal article: bretschneider t., et al (2021) pathologic femur fractures following surgery and radiotherapy for soft tissue sarcomas: a case series, international journal of surgery case reports volume 84, pages 1-5 (switzerland).This study presents three patients with pathological femoral fractures secondary to limb-sparing surgery and radiation therapy in soft tissue sarcomas (sts) patients treated between 2001 and 2008.(case 1) a 41-year-old athletic male who had a myxoid liposarcoma who grad i at his left thigh (deep dorsal compartment).The patient received 60 gy radiation.Thirteen years later he was injured after a low energy fall with his bike and sustained a pathologic displaced left femoral shaft fracture (arbeitsgemeinschaft für osteosynthese fragen [ao] 32-b2).The fracture was treated with an intramedullary stabilisation using a lateral femoral nail (lfn®, depuy synthes, switzerland).Eight months postoperative, the fracture was not yet healed and non-union had to be diagnosed.As the two distal locking bolts were broken, re-stabilisation was achieved by removal of the broken bolts and relocking distally.Another 14 months later, due to a persistent hypertrophic non-union, the medullary canal was reamed again and the nail was changed to a thicker lfn®, 12 mm instead of 10 mm (depuy synthes, switzerland).Two years later the fracture finally healed.(case 2) a 58-year-old female who received a wide r0 excision of a malignant fibrous histiocytoma who grad ii at her left thigh (anterior and partially medial compartment).The operative procedure was followed by radiation therapy with 60 gy.Four years later a local recurrence occurred and was resected again.Another three years later a second local recurrence occurred.Once more a wide excision was performed.A fascio- cutaneous advancement flap was used to cover the resulting defect.Unfortunately, the wound healing was disturbed by a central necrosis of the flap exposing again the femur.The patient refused the recommended new soft tissue coverage by a further operation.One year later the patient fell and suffered a displaced open pathologic left femoral shaft fracture (ao 32-a3) at the site where the bone was uncovered for such a long time.Initial resection of dead bone, stabilisation with an external fixator and wound closure with another local flap was performed.Six weeks after initial trauma, a plate fixation with a reversed less invasive stabilisation system for distal femoral fractures (liss-df®, depuy synthes, switzerland) was performed after bone debridement and shortening of 5 cm.Unfortunately, the patient developed an osteomyelitis and had a chronic fistula with a subsequent non-union of the fracture.Several surgical revisions over the next 4 years including the use of cement spacer, new plates and a third attempt of a soft tissue defect closure did not result in bone healing.Ultimately the patient died due to the development of an uncontrolled pulmonary metastasis and local recurrent disease.The fatal course was not directly related to the local non-union bone problem.(case 3) a 72-year-old female patient a wide excision of a malignant fibrous histiocytoma who grad iii was performed (r0).The tumor was located in the anterior compartment of the left thigh.Received radiation with 66 gy was added locally.Seven years later the patient suffered from sudden pain of the left thigh without any previous trauma.The x-ray showed a non-displaced pathologic left femoral shaft-fracture (ao 32-a2).Initially a fixation with an intramedullary nail (lfn®, depuy synthes, switzerland) was performed.Due to insufficient stability and therefore no progresses in bone healing (the nail was changed twice using thicker implants after reaming of the femur).The x-ray control 3 months postoperative shows a delayed union due to bone healing impairment and insufficient stability.The medullary canal was reamed again and the nail was changed to a thicker lfn®, 12 mm instead of 10 mm (depuy synthes, switzerland).Another 5 months later the x-ray shows a loosening of distal neck screw.Distal neck screw was changed with cement-augmentation.Yet another 7 months later the patient developed a new intertrochanteric femoral fracture after screw and nail breakage proximally (please see figure 4 g red arrow).3 months after re-nailing using a lfn® 12 mm (depuy synthes, switzerland) with cement-augmentation of the neck screws, decortication and autologous cancellous bone grafting, a varisation of the head-neck-fragment with cut out and loosening of one neck screw had to be diagnosed.The implant had to be changed a third time.A liss-df® (depuy synthes, switzerland) was implanted in a reversed manner after performing a closed wedge intertrochanteric valgisation osteotomy.Unfortunately, the wounds did not heal and an uncontrolled deep infection situation worsened the situation dramatically.This resulted in an exarticulation of the left leg at the hip joint performed 22 months after the first osteosynthesis (fig.4a¿j).After that, this patient stayed in rather good shape for the next years with nearly independent personal mobility using a wheel chair.(figure 3, 4a-j).This report is for unknown synthes lfn®, unknown synthes liss-df®.This is report 10 of 10 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: LCP LISS-DF
• Type of Device: PLATE, FIXATION ,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15420657
• MDR Text Key: 299927737
• Report Number: 8030965-2022-06836
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2022
• 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