MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: LCP; PLATE, FIXATION, BONE

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

Device report from synthes reports an event in india as follows: this report is being filed after the review of the following journal article: dheenadhayalan j., et al (2022) reconstruction of massive segmental distal femoral metaphyseal bone defects after open injury a study of 20 patients managed with intercalary gamma-irradiated structural allografts and autologous cancellous grafts, j bone joint surg am.Volume 104- a, number 2 : pages 172-80 (india) this prospective study aims to examine the results of this technique, and our primary objectives were to determine the rate of union, rate of infection, and functional outcome.Between 2010 and 2018, 20 consecutive patients with massive metaphyseal bone defects of the distal femur following an open injury who were treated and had a mean follow-up of 2 years (range, 2 to 10 years) were included in the study.Of these patients, 18 were men and 2 were women.The mean age was 39 years (range, 22 to 72 years).In all patients, a titanium distal femoral locking compression plate (lcp; synthes) was the choice for osteosynthesis.An additional antegrade cephalomedullary nail was used in 1 patient with an ipsilateral subtrochanteric fracture.After excluding 1 patient who was lost to follow-up, 19 patients with complete follow-up were available for analysis.Reported complications: patients who had complications and needed secondary procedures to achieve union: case 1, 72-year-old male had an infected non-union requiring debridement, allograft removal, repeat debridement and cement spacer application, spacer removal and bone-grafting, plate removal and orthofix fixator application and above-the-knee amputation.Case 2, a 45-year-old male had aseptic nonunion of the proximal end with implant failure.The patient had plate removal and application of an ilizarov frame along with bone grafting and achieved union after an 8- month period with a stiff knee.Case 3, 38-year-old male had an infected non-union requiring allograft removal and cement spacer, cement spacer removal and bone-grafting, repeat debridement and implant removal and retrograde nailing, plating, and bone-grafting.Outcome: united (0_-30_ of knee rom).Case 4, a 48-year-old male had early deep ssi requiring allograft removal and cement spacer application in 2 wk and bone-grafting.Outcome: united (0_-30_ of knee rom).Case 5, a 34-year-old male had aseptic nonunion of the proximal end with implant failure.Underwent broken plate removal.Required retrograde nailing, additional plating, and bone-grafting, and achieved union after a 16-month period with knee range of motion of 110_ and 90_.Case 6, a 45-year-old male had aseptic nonunion of the proximal end with implant failure.Underwent broken plate removal and retrograde nailing, plate augmentation, and iliac crest grafting after 14 mo.Outcome: united (0_-90_ of knee rom).Case 7, 24-year-old had late deep ssi following complete union requiring debridement and implant removal.Outcome: united (0_-30_ of knee rom).A copy of the literature article is being submitted with this medwatch.This report involves one unk - plates: lcp.This is report 7 of 11 for (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.This report is for an unknown plates: lcpp/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device available for evaluation: 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.

• Brand Name: UNK - PLATES: LCP
• 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: 16068831
• MDR Text Key: 306347514
• Report Number: 8030965-2022-11648
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 12/29/2022
• 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: 12/06/2022
• 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
• Treatment: UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male