MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: LCP MEDIAL DISTAL TIBIA PLATE/SCREWS; PLATE, FIXATION, BONE

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

Patient Problem Necrosis (1971)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - constructs: lcp/unknown lot.Part and lot numbers are unknown; udi 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

This report is being filed after the review of the following journal article: chung, s.-t.Et al (2009), treatment of distal tibia fracture using mippo technique with locking compression plate: comparative study of the intraarticular fracture and extraarticular fracture, journal of korean foot and ankle society, vol.13 (2), pages 162-168 (korea, south).The aim of this study is to evaluate the efficiency of the minimally invasive percutaneous plate osteosynthesis (mippo) with locking compression (lcp) for distal tibial metaphyseal intra-articular fracture compared with extra-articular fracture.Between february 2006 to june 2008, a total of 41 patients who were treated operatively by mippo technique were included in the study.They were divided into extra-articular fractures and intra-articular fractures.In the extra-articular fractures, there were 20 patients (10 male and 10 female) with a mean age of 52.35 years (range: 28-77 years).In the intra-articular fractures, there were 21 patients (15 male and 6 female) with a mean age of 48.85 years (range: 24-76 years).Surgery was performed using a locking compression plate (lcp, distal medial tibia plate, synthes, swiss).The mean follow-up period for the intra-articular fracture and extra-articular fracture was 14.5 months (range: 12-19 months) and 15 months (range: 12-23 months), respectively.The following complications were reported as follows: a (b)(6) year-old female patient had skin irritation/discomfort due to the protrusion of the distal part of the plate; had 5 degrees dorsiflexion limitation compared to the unaffected side.A (b)(6) year-old female patient had skin irritation/discomfort due to the protrusion of the distal part of the plate; had 5 degrees dorsiflexion limitation compared to the unaffected side.A (b)(6) year-old female patient had 10 degrees dorsiflexion limitation compared to the unaffected side.A (b)(6) year-old male patient had 5 degrees plantar flexion limitation compared to the unaffected side.A (b)(6) year-old female patient with diabetes mellitus developed skin necrosis at the surgical site but was healed with conservative treatment; had 5 degrees dorsiflexion limitation compared to the unaffected side.A (b)(6) year-old male patient developed a superficial infection, but it improved with antibiotic treatment.A (b)(6) year-old female patient had 15 degrees plantar flexion limitation compared to the unaffected side.A (b)(6) year-old male patient had 5 degrees dorsiflexion limitation compared to the unaffected side.A (b)(6) year-old male patient had skin irritation/discomfort due to the protrusion of the distal part of the plate; had 5 degrees dorsiflexion limitation and 15 degrees plantar flexion limitation compared to the unaffected side.A (b)(6) year-old female patient developed skin necrosis; had 5 degrees and 15 degrees of dorsiflexion and plantar flexion limitation, respectively.A (b)(6) year-old male patient had 5 degrees dorsiflexion limitation.A (b)(6) year-old male patient had 5 degrees dorsiflexion limitation.A (b)(6) year-old female patient had 5 degrees dorsiflexion limitation.A (b)(6) year-old male patient had skin irritation/discomfort due to the protrusion of the distal part of the plate.A (b)(6) year-old male patient had 5 degrees plantar flexion limitation.A (b)(6) year-old female patient had both 5 degrees dorsiflexion and plantar flexion limitation.A (b)(6) year-old male patient had skin irritation/discomfort due to the protrusion of the distal part of the plate; had 5 degrees of plantar flexion limitation.A (b)(6) year-old female patient had 5 degrees plantar flexion limitation.A (b)(6) year-old male patient had both 5 degrees of dorsiflexion and plantar flexion limitation.A (b)(6) year-old female patient had both 10 degrees of dorsiflexion and plantar flexion limitation.A (b)(6) year-old female patient had skin irritation/discomfort due to the protrusion of the distal part of the plate; had 5 degrees of plantar flexion limitation.A (b)(6) year-old female patient had 15 degrees of plantar flexion limitation.A (b)(6) year-old male patient had 5 degrees and 10 degrees of dorsiflexion and plantar flexion limitation, respectively.A (b)(6) year-old male patient had 10 degrees and 5 degrees of dorsiflexion and plantar flexion limitation, respectively.A (b)(6) year-old female patient had 5 degrees of dorsiflexion limitation.A (b)(6) year-old male patient with an unsatisfactory result where the timing of the ankle movement was delayed due to post-operative skin necrosis in the open area and the plantar flexion limit was measured to be 20 degrees.Also, the time of bone union was late at 24 weeks.A (b)(6) year-old male patient had both 5 degrees of dorsiflexion and plantar flexion limitation.A (b)(6) year-old male patient had both 5 degrees of dorsiflexion and plantar flexion limitation.A (b)(6) year-old male patient had both 10 degrees of dorsiflexion and plantar flexion limitation.A (b)(6) year-old male patient had 5 degrees of plantar flexion limitation.A (b)(6) year-old male patient had both 5 degrees of dorsiflexion and plantar flexion limitation.A (b)(6) year-old female patient had 5 degrees and 10 degrees of dorsiflexion and plantar flexion limitation, respectively.A (b)(6) year-old male patient had both 5 degrees of dorsiflexion and plantar flexion limitation.A (b)(6) year-old male patient had 5 degrees of dorsiflexion limitation.A (b)(6) year-old male patient had skin irritation/discomfort due to the protrusion of the distal part of the plate.A (b)(6) year-old male patient had skin irritation/discomfort due to the protrusion of the distal part of the plate.This report is for an unknown synthes lcp medial distal tibial plate/screws constructs, unknown synthes lcp medial distal tibial plate, and unknown synthes locking screws.This report is for (1) unk - constructs: lcp.This is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.D1: updated impacted product.H3, h6: the investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 - CONSTRUCTS: LCP MEDIAL DISTAL TIBIA PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12380539
• MDR Text Key: 268682669
• Report Number: 8030965-2021-07328
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention