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

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

Patient Problems Bone Fracture(s) (1870); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)

Event Date 01/22/2022

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: kim, j.H.Et al (2022), new classification for periprosthetic distal femoral fractures based on locked-plate fixation following total knee arthroplasty: a multicenter study, the journal of arthroplasty, vol.Xx (xx), pages 1-8 (korea, south).The aim of this multicenter retrospective study was to establish a new classification using locked-plate fixation for periprosthetic distal femoral fracture (pdff) following total knee arthroplasty (tka) and to determine when dual locked-plate fixation is necessary through defining this classification.Between april 2011 to december 2019, a total of 115 patients (11 male and 104 female) with a mean age of 71.1 ± 8.2 years who underwent operative treatment were included in the study.Among them, a single lateral locked-plate fixations were performed using an anatomically precontoured locked plate (lcp distal femur plate; synthes gmbh, (b)(4)) in 69 patients with a type i, 10 patients with type iil, and 10 patients with type iim pdffs, while 3 patients were implanted with a competitor device.3 patients with type iim underwent a single medial locked-plate and 15 patients with type iim underwent a dual locked-plate.Plates for medial fixation included the anatomical locked plate for the proximal humerus (philos; synthes gmbh, (b)(4)) and locked plate for the medial distal femoral osteotomies (tomofix medial distal femur; synthes gmbh).A mean follow-up period was 27.1 ± 22.8 months (range 12.0-108.0).The following complications were reported as follows: type i (lcp distal femur plate): an unknown number of patients with synthes had complications (includes delayed or nonunion, deep vein thrombosis, refracture, and infection).3 of these with synthes had a delayed union due to the short length of the plate.Type iil (lcp distal femur plate): 11 patients had complications (which include delayed or nonunion, deep vein thrombosis, refracture, and infection).7 of these patients had bone union-related complications.Type iim single locked-plate (lcp distal femur plate): 6 patients had complications (which include delayed or nonunion, deep vein thrombosis, refracture, and infection).Among these, 1 had delayed union and 4 had nonunion.Type iim dual locked-plate (philos/tomofix medial distal femur): 2 patients had complications (which include delayed or nonunion, deep vein thrombosis, refracture, and infection).Among these, 1 had delayed union.This report is for an unknown tomofix medial distal femur construct.This is report 1 of 3 for (b)(4).A copy of the literature article is being submitted with this medwatch.

Manufacturer Narrative

Between april 2011 to december 2019, a total of 115 patients (11 male and 104 female) with a mean age of 71.1 ± 8.2 years who underwent operative treatment were included in the study.This report is for an unknown tomofix medial distal femur 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.

• Brand Name: UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS: MEDIAL DISTAL FEMUR
• 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: 13905691
• MDR Text Key: 291389907
• Report Number: 8030965-2022-01956
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• 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: 02/25/2022
• 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