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 Arthritis (1723); Bone Fracture(s) (1870); Nerve Damage (1979); Pain (1994); Post Operative Wound Infection (2446); Joint Laxity (4526)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown tomofix construct/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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: miettinen, s.Et al.(2021), midterm follow-up results of two different types of implants in opening wedge high tibia osteotomy, the knee, vol.31, pages 11-21 (finland).The aim of this retrospective comparative study was to evaluate midterm results in medial knee osteoarthritis (oa) patients, treated by medial open-wedge high tibial osteotomy (mowhto) at a single center using these implants.Between january 2004 and december 2014, there were 157 patients (167 knees) who underwent mowhto using a precountered locking compression plate (lp) (tomofix, synthes, umkirch, germany).The osteotomy gap was filled in 121/241 knees with bone substitutions using a chronostm, synthes, umkirch, germany.There were 138 males and 29 females with a mean age of 48.2 years.The mean follow-up time was 6.0 years (sd = 3.0, range 0.2¿12.8 years).The following complications were reported as follows: 11 patients had intraoperative complications.44 patients had revision surgeries (implant removal.Tka, anterior knee cruciate ligament reconstruction, implant exchange) due to: 22 patients for pain, 17 patients for progression of osteoarthrosis, 2 patients for nonunion, 2 patients for instability, and 1 patient for infection.1 patient had a nerve injury.3 patients had lateral cortex fracture.This report is for an unknown synthes tomofix construct.It captures the reported revision surgeries for pain, progression of osteoarthrosis, nonunion, instability, infection, nerve injury and ateral cortex fracture.This is report 1 of 2 for (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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12480868
• MDR Text Key: 271692108
• Report Number: 8030965-2021-07779
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• 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: 09/01/2021
• 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