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

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

Patient Problems Bone Fracture(s) (1870); Nerve Damage (1979); Loss of Range of Motion (2032); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446); Malunion of Bone (4529); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown construct/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between 2000 to 2017.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.(b)(4).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: della rotonda g., et al(2020) analysis of early and late clinical and radiologic complications of proximal humeral fractures using open reduction, internal fixation, and intramedullary titanium cage augmentation,journal of shoulder and elbow surgery volume 29, pages 1843-1851 (italy) https://doi.Org/10.1016/j.Jse.2020.01.077.This study aims to report the advantages or disadvantages and inoperative, postoperative, early, and late clinical and radiologic complications of the aforementioned hybrid technique in a group of patients treated from 2005 to 2017 with long-term follow-up.From 2000 to 2017, 937 proximal humeral fractures were treated from pinning to reverse shoulder prosthesis.From 2005 to 2017, 142 nonconsecutive patients (93 women and 49 men) with an average age of 64 years (range, 28-80 years) having proximal humeral fractures were treated with the described technique.All 142 patients were followed up until 2 years, but only 115 patient could be considered to have long-term follow-up, between 7 and 12 years, because 14 patients died, 6 were lost to follow-up.The intramedullary da vinci cage (arthrex, naples, fl, usa) in all fractures.To achieve an anatomic and stable bone reconstruction a nonabsorbable osteo-sutures, k-wires, and plates (depuy synthes, raynham, ma, usa) were used.Different types of flexible plates: tubular malleolar plates, titanium nonlocked plates, and philos proximal humeral locking plates (depuy synthes).The following complications were reported as follows: 14 patients died.A case of a male patient had stable nonunion with partial functional nonunion of humeral neck at 10 years¿ follow-up and good left shoulder function.A case of a male patient had anterior fracture dislocations had an active motion reduction, with a decrease in motion from 135 at 5 years to 90 at 10 years.1 axillary nerve palsy after 3 months was observed.A varus displacement of the head in 4 cases.Tuberosity nonalignment in 2.Fair, 12 and poor, 4 clinical examination findings,radiographic results, and patient satisfaction results.Malunion, associated with a displacement of both tuberosities greater than 5 mm from their anatomic position, was observed in 2 patients.Hypertrophic atraumatic nonunion of the humeral neck was observed in 1 patient.Bone loss and osteosclerosis suggestive of ischemic damage to the head were observed in 8 patients.A secondary partial area of cartilage changes was observed in 9 patients , of whom 2 underwent a shoulder prosthesis procedure between 2 and 7 years after primary surgery.Among the first 15 patients treated between 2005 and 2006, 1 superficial infection and 1 deep infection, resistant to antibiotic therapy,the latter was treated successfully by removal of the infected and necrotic head and cement spacer implantation, whereas the former was treated by administration of a specific antibiotic for 6 months.1 deltoid paralysis.In the long term, 3 patients with anterior fracture dislocations had an active motion reduction, with a decrease in motion from 135 at 5 years to 90 at 10 years.A transitory axillary nerve palsy with inferior humeral head subluxation, as was commonly reported in the literature, was observed in 41 patients ( patients treated from 2006 to 2017) the complete resolution of this transitory malfunction was observed in 40 patients with a minimum time frame of 3 months and in 1 patient with a maximum time frame of 16 months.In 1 complex case of a 3-part fracture, a complication was observed after 6 months owing to plate breakage associated with varus inclination of the head of 15.The plate was removed after 2 years with improvement of the range of motion from 120 of elevation after 3 years to 155 at 10 years.This report is for an unknown synthes philos proximal humeral locking plates (depuy synthes).A copy of the literature article is being submitted with this medwatch.This report is for one (1) unknown construct.This is report 3 of 4 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11445632
• MDR Text Key: 249709250
• Report Number: 8030965-2021-01752
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 02/11/2021

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: 02/11/2021
• Initial Date FDA Received: 03/09/2021
• 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