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 Impaired Healing (2378); Post Operative Wound Infection (2446)

Event Date 08/25/2021

Event Type  Injury  

Manufacturer Narrative

Literature citation: heinz, t.Et al (2021), focal cartilage defects of the lateral compartment do influence the outcome after high tibial valgus osteotomy, sicot-j, vol.7 (44), pages 1-8 (germany).This report is for an unknown biomaterial - preformed: chronos: trauma 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: heinz, t.Et al (2021), focal cartilage defects of the lateral compartment do influence the outcome after high tibial valgus osteotomy, sicot-j, vol.7 (44), pages 1-8 (germany).The aim of this retrospective study is to assess the functional outcome as measured by the knee and osteoarthritis outcome score (koos) after hto for osteoarthritis of the medial compartment in varus aligned knees was performed.Between august 2005 to march 2012, a total of 63 patients (54 male and 9 female) with a mean age of 39 years (range from 14 to 58 years) who underwent high tibial valgus osteotomy (hto) were included in the study.In every case, a medial open-wedge approach was used and a tomofix® plate secured the osteotomy.The medial wedge was left unfilled or filled using autologous spongiosa or bone graft substitute (chronos®).The mean follow-up period averaged 46.1 ± 24.3 months (10.0¿93.0 months).The following complications were reported as follows: 2 patients suffered from postoperative wound infections that could be successfully addressed solely by the prolonged administration of antibiotics without the need for operative revision surgery.In 1 case, a prolonged bone healing process was addressed properly by a prolonged period of partial weight-bearing.In 2 cases, conversion to total knee arthroplasty (tka) has been documented, the first after 6.2 years and the second after 8.5 years after the index procedure.This report is for an unknown synthes tomofix plate/screws constructs and unknown synthes chronos.A copy of the literature article is being submitted with this medwatch.This is report 2 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13909122
• MDR Text Key: 291387587
• Report Number: 8030965-2022-01884
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• 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: 02/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention