MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS; PLATE, FIXATION, BONE

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

Patient Problems Cellulitis (1768); Muscular Rigidity (1968); Pain (1994); Post Operative Wound Infection (2446); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - constructs: tomofix plate/screws/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: corbeil, v., synnott, p.A., al-shakfa, f., and lavoie, f.(2021), medial opening wedge proximal tibial osteotomy: lessons learned from a series of 175 consecutive cases, cartilage, vol xx, pages 1-15 (canada).The goal of the study was to assess and identify factors influencing functional outcome of medial opening wedge proximal tibial osteotomies in patients with medial knee osteoarthritis.Between 2008 and 2016, a total of 155 patients (175 knees; 118 males and 57 females with a mean age of 49.5 years) with medial knee osteoarthritis underwent medial openwedge valgus high tibial osteotomy (hto) using the tomofix plate (depuy-synthes, west chester, pa, usa).The following complications were reported as follows: minor complications.62 patients returned to the hospital prior to their planned follow-up.17 patients had cellulitis.1 patient had blisters.1 patient had purpuric rash.1 patient had intense pain.17 patients had superficial infectons which were treated for the most part with an initial dose of intravenous antibiotics followed by oral antibiotic treatment.Six of the 17 superficial infections required readmission.Other complications were related to postoperative leg swelling and resolved spontaneously.Major complications: 3 patients had deep infections which were treated using intravenous antibiotics and surgical lavage.11 patients were treated for a thromboembolic complication, 10 infrapopliteal thromboses and 1 case of suprapopliteal thrombosis; every case was treated with oral anticoagulants on an outpatient basis.9 patients had hospital readmissions.Reoperation: 43 patients were eventually reoperated for plate removal because of residual pain.Three patients ere revised to tka after an average of 2.1 years following hto due to residual pain and stiffness.Eleven knees were converted to tka after an average of 4.4 years.This report is for an unknown synthes tomofix.This report is for one (1) unk - constructs: tomofix plate/screws.This is report 1 of 1 for complaint (b)(4).

• Brand Name: UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12562382
• MDR Text Key: 274278988
• Report Number: 8030965-2021-08249
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention