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

Device Problem Migration (4003)

Patient Problems Unspecified Infection (1930); Non-union Bone Fracture (2369); Fluid Discharge (2686)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: kamson, a., and siska, p.(2023), management and surgical optimization of failed distal femur fractures, operative techniques in orthopaedics vol.33 (101045), pages 1-7 (usa).This study will provide a review of the principles of distal femoral nonunion treatment as well as to highlight preferred fixation strategies.During the conduct of the study, there were 3 patients (all female) with a mean age of 69.6 years (59-83) are included.All patients had failed distal femur fracture fixation with depuy synthes lcp.These patients undergo nonunion reconstruction with different strategies.The following complications were reported as follows: a 59-year-old healthy female with supracondylar periprosthetic distal femur fracture had fracture fixation with depuy-synthes lcp that develops to nonunion nonunion reconstruction of distal femur utilizing a depuy synthes proximal humerus locking plate medially that went on to successful bony union.A 67-year-old morbidly obese female with periprosthetic distal femur fracture and with long oblique fracture extending to diaphyseal region had fracture fixation with depuy-synthes lcp that develops to nonunion.Mechanical failure and screw loosening with varus collapse was noted and there was a paucity of bone healing nonunion reconstruction of distal femur utilizing a depuy synthes retrograde intramedullary nail (rimn) and lateral locking plate (lcp) that went on to successful union.An 83-year-old female with a comminuted distal femur fracture treated with a locking plate had fracture fixation with depuy-synthes lcp that develops to nonunion.Had an infected nonunion post operative course complicated by hardware failure, varus collapse, and wound drainage.Underwent staged reconstruction and distal femur replacement.This report is for an unknown depuy-synthes lcp distal femur plate.It captures the reported 83-year-old female who developed infected nonunion and post operative course complicated by hardware failure, varus collapse, and wound drainage.A copy of the literature article is being submitted with this medwatch.This is report 3 of 5 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.G4-510k: this report is for an unknown lcp distal femur plate/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H6: without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 DISTAL FEMUR
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 18369494
• MDR Text Key: 331047588
• Report Number: 8030965-2023-15962
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• 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: 83 YR
• Patient Sex: Female