MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: DHS/DCS; APPLIANCE, FIXATION, NAIL

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

Patient Problems Hematoma (1884); Post Operative Wound Infection (2446)

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown constructs: pfna/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: müller, m.Et al (2020), the association between high body mass index and early clinical outcomes in patients with proximal femur fractures, journal of clinical medicine, vol.9 (7), pages 1-13 (germany).The aim of this single-center retrospective cohort study is to evaluate the association between bmi and postoperative complications, functional outcomes, length of hospitalization, and mortality after proximal femur fractures with a focus on the early postoperative period.Between 2003 to 2015, a total of 950 patients (313 male and 637 female) with a mean age of 74.8±13.51 years (range 23¿99 years) were included in the study.Trochanteric fractures were treated with a cephalomedullary nailing system (proximal femoral nail antirotation system, synthes gmbh, oberdorf, switzerland; or competitor device) in 398 patients or with a dynamic hip screw (dhs dynamic hip system, depuy synthes gmbh, oberdorf, switzerland) in 46 patients.Femoral neck fractures were treated with a dynamic hip screw in 81 patients or arthroplasty in 425 patients.No follow-up examinations were performed.The following complications were reported as follows: in-hospital mortality was 2% (9 patients) in patients with trochanteric femur fracture while 4.3% (22 patients in femoral neck fracture.80 patients underwent revision within the first two years.Reasons for revision were relevant postoperative hematoma, deep wound site infection, and infection or dislocation of the arthroplasty.The overall incidence of all dislocations in thas or has was 2.4% (n = 10/415).Ob patients had slightly more dislocations.The results had no significance (uw: n = 3, 3.8%; nw: n = 15, 2.6%; ow: n = 5, 2.1%; ob: n = 2, 3.4%).27 patients had wound site infection.86 patients had urinary tract infection.44 patients had pneumonia.12 patients had deep vein thrombosis.12 patients had implant failure.This report is for an unknown synthes pfna constructs and unknown synthes dhs constructs.

• Brand Name: UNK - CONSTRUCTS: DHS/DCS
• Type of Device: APPLIANCE, FIXATION, NAIL
• 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: 11385963
• MDR Text Key: 240165159
• Report Number: 8030965-2021-01404
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/04/2021

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: 02/04/2021
• Initial Date FDA Received: 02/26/2021
• 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