MAUDE Adverse Event Report: SYNTHES GMBH UNK - KITS/SETS: FNS IMPLANT KIT; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

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

Patient Problem Physical Asymmetry (4573)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: cintean, r.Et al (2021), early results in non-displaced femoral neck fractures using the femoral neck system, geriatric orthopaedic surgery & rehabilitation, vol.12 (xx), pages 1¿7 (germany).The aim of this retrospective study was to compare the outcome of elderly patients with multiple comorbidities with undisplaced femoral neck fractures treated with a hemiarthroplasty or the new femoral neck system.Between june 2018 and june 2020, a total of 63 patients (31 male and 32 female) with femoral neck fractures classified garden i were included in the study.Of these, 29 patients (14 male and 15 female; mean age of 79.57 years) were treated with the femoral neck system (fns, depuy-synthes, zuchwil, switzerland) with a one-hole plate under fns group.In the ha cohort, 34 patients (17 male and 17 female; mean age of 80.35 years) received the same combination of implants with corail amt stem and a self-centring bipolar head (depuy-synthes).The mean follow-up in ha cohort was 12.5 (0¿22) months, in the fns group 3.9 (0¿18) months.The following complications were reported: fns group: 2 patients died during hospitalization due to cardiopulmonary complications.4 patients had a cut-out of the femoral neck system.Three patients needed a conversion into a ha after an average of 26 days (14¿58 days).One patient with a minor cut-out was bedridden and only an implant removal was performed for pain management after 18 months.21 patients had showed shortening of the femoral neck.Mean shortening was 3.3 ± 4.5 mm (2¿9 mm).Four of these patients (19%) showed shortening of > 5 mm in the radiographic control after 3 months.In the limited time of follow-up, no case of avascular necrosis of the femoral head was found.Except one patient with minor cut-out, 20 (95.2%) patients showed radiographic signs of bone healing after 3 months.This report is for an unknown synthes femoral neck system.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Patient id, age or dob, sex, weight: there are multiple patients.All known information is provided in the literature article.Pma/510k: this report is for an unknown femoral neck system/unknown lot.Part and lot number are unknown; udi number is unknown.Device available of evaluation: 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 - KITS/SETS: FNS IMPLANT KIT
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 14458444
• MDR Text Key: 292710097
• Report Number: 8030965-2022-03327
• 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,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• 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: 04/20/2022
• 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