MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: LCP; PLATE, FIXATION, BONE

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

Patient Problems Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/06/2022

Event Type  Injury  

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.Additional narrative: this report is for an unknown construct: lcp/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: suh d., et al (2022) use of an intramedullary fibular strut allograft and dual locking plate in periprosthetic fractures above total knee arthroplasty: new application of a well-known treatment method in trauma, european journal of trauma and emergency surgery xxxx, pages 1-7 (korea, south) this study aims to report the outcome of first case series demonstrating the novel application of an intramedullary fibular allograft strut and dual locking plates on complicated periprosthetic fracture of distal femur.Between january 2018 and april, the patient demographics, weight-bearing status, and radiographic and clinical outcomes of 23 patients were reviewed.Of 23 patients, 4 patients without fracture comminution were treated with lateral locking plating, 13 patients were with medial wall comminution only, and treated with dual locking plating and 7 patients with both medial and lateral cortical comminution were treated with intramedullary fibular strut allograft augmentation combined with dual locking plating.Of the seven, one patient who was not followed up for more than 6 months was excluded.Finally, six patients who were treated with intramedullary fibular allograft strut augmentation combined with dual locking plating were included in this study.The median age at the time of injury was 81 (range 78¿89) years old.5 patients were female, and one patient was male.During fixation, lateral femoral locking-compression plate (lcp; synthes gmbh, switzerland) and a tomofix medial distal femoral plate (synthes gmbh, switzerland) were placed on lateral and medial cortex.While applying compressive force onto plates from bilateral side, the locking plates are fixed with locking screws.All patients were followed up for at least 6 months after surgery.Reported complications: all patients reached self- ambulatory state without assistance at 1-year follow-up, except for one case, a 79-year-old female, where crutch was required due to prolonged discomfort.Also had occasional pain up to vas score 3, which falls into criteria ¿good to fair¿ postoperative pain.The knee range of motion was assessed as ¿good to fair¿, where good has none to occasional pain and fair has less than 10° extension deficit more than 60° total rom, slight pain always, less than 10° varus or valgus and shortening of less than 3 cm, because all patients had flexion contracture between 10°¿20° and further flexion between 80° and 110°.None of these patients underwent subsequent surgery regarding the injury.This report is for an unk - construct: lcp.A copy of the literature article is being submitted with this medwatch.This is report 3 of 4 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: LCP
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15494538
• MDR Text Key: 300702791
• Report Number: 8030965-2022-07433
• 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
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• 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: 09/07/2022
• 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): Other