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

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

Patient Problems Pain (1994); Physical Asymmetry (4573)

Event Date 08/25/2021

Event Type  Injury  

Manufacturer Narrative

Exact date of even is unknown; august 25, 2021 is the date the literature article was published.This report is for an unknown tomofix medial high tibia construct/unknown lot.Part and lot number 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: maeda, s.Et al (2021), the difficulty of continuing sports activities after open-wedge high tibial osteotomy in patient with medial knee osteoarthritis: a retrospective case series at 2-year-minimum follow-up, journal of experimental orthopaedics, vol.8 (68), pages 1-8 (japan).The aim of this retrospective case series was to investigate the rate at which patients returned to sports after open wedge high tibial osteotomy and identify the continuity of sports activity post-operatively.Between april 2010 to january 2019, a total of 35 patients (40 knees; 27 males and 8 females) who underwent open-wedge high tibial osteotomy (ow-hto) were included in this study.The mean age of the patients who underwent surgery was 55.1 ± 10.7 years.Surgery was performed using tomofix (depuy synthes, bettlach, switzerland) or competitor devices.The mean follow-up period was 41.0 ± 24.7 months.The following complications were reported as follows: an unknown number of patients with synthes device underwent conversion to tka after approximately 7 years due to affected knee pain.In radiographic parameters of an unknown number of patients with synthes device, the weight-bearing line ratio was considered loss of correction in the post-operative period leading to the final follow-up.This report is for an unknown tomofix medial high tibia construct.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS: MEDIAL HIGH TIBIA
• 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: 13922222
• MDR Text Key: 293165532
• Report Number: 8030965-2022-01962
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2022
• 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: 02/25/2022
• 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