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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Hematoma (1884)

Event Date 02/11/2021

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: herbst, m.Et al.(2021), overweight patients benefit from high tibial osteotomy to the same extent as patients with normal weights but show inferior mid-term results, knee surgery, sports traumatology, arthroscopy, vol.Xx, pages 1-11 (b)(6).The purpose of this prospective study was to analyze the impact of obesity on the clinical and radiological outcomes 6 years after open-wedge high tibial osteotomy (hto).Between 2008 and 2011, 120 consecutive and prospectively assessed patients underwent medial open-wedge hto surgery using an unknown synthes tomofix.The mean age was 54.6 years.Of 120 patients, 85 had at least a 6-year follow-up (mean 6.7 years, range 6¿11.8 years).The following complications were reported as follows: 9 patients converted to total knee arthroplasty.1 patient had hematoma which required a second intervention, but subsequently healed without consequence.4 patients had subcutaneous infections that did not require further surgery and also healed without consequence.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: 12548497
• MDR Text Key: 274221528
• Report Number: 8030965-2021-08134
• 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,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention