MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PFN; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problem Necrosis (1971)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unk - constructs: pfn/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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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

Device report from synthes reports an event in argentina as follows: this report is being filed after the review of the following journal article: godoy-monzon, d.Et al.(2020), conversion total hip arthroplasty with a proximally modular, distal fixation reconstruction prosthesis following cephalomedullary nail failure, hip international, vol.30(1s), pages 26-33 (argentina).The purpose of this retrospective case series was to evaluate the clinical and radiographic results of conversion total hip arthroplasty utilizing an uncemented or cemented modular femoral stem (mfs) for hip reconstruction following a cephalomedullary nail (cmn) failure.Between 2012 and 2014, 28 patients with intertrochanteric hip fracture (ihf) had femoral cephalomedullary nail (cmn) failures and had a total hip arthroplasty conversion utilizing a modular femoral stem (mfs).There were 17 females and 11 males with an average age of 72.7 years.Cmns used in the patients included the proximal femoral nail in 13 patients (pfn, depuy synthes trauma, west chester, pa, usa), the trochanteric femoral nail in 9 patients (tfn, depuy synthes trauma, west chester, pa, usa) or the gamma3 nailing system in 6 patients (gamma3 nailing system, stryker, mahwah, nj, usa).The average time from the index procedure to conversion tha was 12.6 months.The article did not specify which of the devices were being used to capture the following complications: 11 patients had osteoarthritis.7 patients had avascular necrosis/head collapse.5 patients had pseudoarthrosis.4 patients had cmn nail migration into the joint space.1 patient had cmn breakage.This report is for an unknown synthes pfn and tfn.Note: surgeries were done in 3 different hospitals, all with resident programs.The accumulate primary cmn procedures.During the evaluated period was 329 cases as you see the arthrosis progress is not result of the implant.The failure rate as part of fracture complexity, teaching to residents learning curve, patients related issues.This report is for (1) unk - constructs: pfn.This is report 2 of 4 (b)(4).

• Brand Name: UNK - CONSTRUCTS: PFN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: 11380793
• MDR Text Key: 241044122
• Report Number: 8030965-2021-01366
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: AR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 02/25/2021
• 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