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

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

Patient Problems Joint Dislocation (2374); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown liss 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: tuncay, i.Et al.(2021), onlay fibula autografting technique and its comparison with cortical allograft for the reconstruction of periprosthetic bone defects around the femur, international orthopaedics, vol.45, pages 71-81 (turkey).The purpose of the present study was to describe surgical technique of using fibula strut autograft and compare its outcomes to cortical allografts in the reconstruction of bone defects.Between december 1999 and april 2018, a total of 53 patients were evaluated who underwent revision hip arthroplasty and/or periprosthetic fractures (pff) fixation with the use of onlay cortical fibula autograft (fg group) or cortical allograft (cg group).For the periprosthetic fracture cases, a direct lateral approach is used, the fracture is reduced and fixed preferentially using limited contact, locking compression plates (lcp), or distal femur locking compression plates (liss) according to the level of the fracture in the fg group.There were 40 patients (37 female, 92.5%) with a minimum follow-up of 2 years (mean 7.1 years, ranging from 2.3 to 18 years) and with the mean age of 65.3 ± 13.5 years (range, 38 to 90 years).The following complications were reported as follows: 3 patients had hip dislocation: one revised with constrained cup, one with dual mobility cup, and one patient who had accompanying acute prosthetic joint infection treated with dair procedure with removal of the grafts and open reduction.1 patient underwent acetabular component revision due to early loosening.This report is for an unknown synthes liss construct.This report captures the reported events of 3 patients who had hip dislocation: one revised with constrained cup, one with dual mobility cup, and one patient who had accompanying acute prosthetic joint infection treated with dair procedure with removal of the grafts and open reduction.This is report 2 of 4 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: LISS 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12497423
• MDR Text Key: 272862747
• Report Number: 8030965-2021-07866
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• 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: 09/08/2021
• 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