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 Problem Physical Asymmetry (4573)

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: iseki t., et al (2021) double-level osteotomy for severe varus osteoarthritic knees can prevent change in leg length and restore physiological joint geometry, the knee volume 31 , pages 136¿143 (japan) this study aims to examine the postoperative changes in leg length as well as radiological and clinical outcomes following dlo as compared with the data obtained from knees undergoing isolated ow-hto in surgical treatment of severe varus knee deformity.Between april 2015 and march 2017, a consecutive series of 206 patients undergoing osteotomy around the knee for unicompartmental oa with varus or valgus deformity were initially enrolled in this comparative study.A total of 64 patients who met the inclusion/exclusion criteria constituted the subjects of this study for the analysis.29 patients ( 5 malesand 24 females ) age 62.8 ± 5.8 (50¿79 years ) with dlo and 35 patients (22 males and 13 females) age 63.9 ± 13.7 (26¿79 years ) with ow-hto were included in the study.Dlo was performed using a minimally invasive biplanar osteotomy procedure combined with the mipo technique for fixation.The tomofix mdf (medial distal femur) (anatomical plate (depuy synthes, solothurn, switzerland) originally designed for the contralateral side was bent according to the individual¿s anatomy and utilized for the fixation.During the procedure, the alignment and amount of correction produced by the osteotomy were checked and adjusted using an alignment rod under fluoroscopic control and compared with the preoperative planning.The femoral osteotomy was performed to attain the intended radiological parameter with mldfa of 85_.Afterwards, the surgery was completed with a modified ow-hto to attain the intended radiological parameters with mmpta of 90_, and hka of 1¿2_ (a slight valgus position with %ma of approximately 52¿55%).A bone substitute (ss-tcp: osferion 60; olympus terumo biomaterials, tokyo, japan) was inserted into the osteotomy gap after opening the wedge.A tomofixtm medial high tibial (mht) plate (depuy synthes, solothurn, switzerland) was placed anteromedially to achieve the fixation of the tibial osteotomy.All patients were followed up for a minimum of 2 years after surgery, and the mean time between the surgery and the follow up was 37.2 ± 13.6 months (range, 24¿60 months).The following complications were reported as follows: ow-hto group: -when the postoperative value was examined for each case, the resultant mmpta was less 33 of the 35 knees in the ow-hto group while two knees in latter group exhibited an mmpta angle of more than 95.The radiological evaluation of the alignment and geometric parameters in the ow-hto group showed that correction of coronal limb alignment was attained as intended, while the average postoperative mmpta (91.5 degrees) exceeded the normal range in two of the 35 knees exhibiting 95 degrees.This report is for an unknown synthes tomo fixtm medial high tibial (mht) plate and unknown synthes tomofix mdf (medial distal femur) (anatomical plate.A copy of the literature article is being submitted with this medwatch.This report is for one (1) unk - constructs: tomofix plate/screws.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: e1 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.D1.

• 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: 12548215
• MDR Text Key: 273981503
• Report Number: 8030965-2021-08128
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention