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

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

Patient Problems Bone Fracture(s) (1870); Necrosis (1971); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

Unknown event date.510k: this report is for an unknown philos construct/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

Device report from synthes reports an event in germany as follows: this report is being filed after the review of the following journal article: dey hazra, r.-o.Et al (2022), age-independent clinical outcome in proximal humeral fractures: 2-year results using the example of a precontoured locking plate, journal of clinical medicine, vol.11 (408), pages 1-10 (germany).The aim of this retrospective study was to investigate whether age influences the efficacy of locking plate osteosynthesis by comparing the functional outcomes of patients =65 years and <65 years.Among the 131 patients (132 phfs) who underwent primary fracture fixation of a displaced phf with the titanium alloy philos plate (depuy synthes®; synthes gmbh, umkirch, germany), 79 patients were included in the study between january 2017 and january 2018.The cohort was divided into two groups: group 1 (=65 years) and group 2 (<65 years).Group 1 consists of 42 patients (10 male and 32 female) with a mean age of 74.4±6.6 years (range: 65¿89 years) and mean follow-up time of 25 months (range: 19¿29 months).Group 2 consists of 37 patients (17 male and 20 female) with a mean age of 52.9±8.9 years (range: 29¿65 years) and a mean follow-up time of 24 months (range: 14¿29 months).The following complications were reported as follows: among the excluded patients, 3 patients died.Group 1: regarding the quality of fracture reduction, 18 patients had a malreduction.3/20 cases had secondary screw perforation.2 of these cases required revision surgery; one case was in the cement-augmented humeral head screw subgroup, and the other was in the subgroup without cement.2/20 cases had a fragment displacement, both involving displacement of the greater tubercle.2 patients had avascular necrosis.A 70-year-old female with a valgus-distracted four-part fracture experienced osteonecrosis of the humeral head 4 months after primary surgery and were treated using reverse shoulder arthroplasty.An 81-year-old female presented with osteonecrosis of the humeral head 5 months after primary plate osteosynthesis, and treatment was also switched to reverse shoulder arthroplasty.Group 2: regarding the quality of fracture reduction, 11 patients had malreduction.4/26 cases had a secondary screw perforation.4 patients suffered an avascular humeral head necrosis, leading to three reverse arthroplasties and one anatomical shoulder arthroplasty.In two cases, divergent from the treatment algorithm, humeral head-preserving reconstruction was performed even though both fractures had a humeral headsplit component.The other two cases showed a varus-distracted pattern with a severe commuted humeral head requiring allogeneic bone transplantation.Late infection was observed in a 53-year-old female with diabetes mellitus type 2 (on medication) who had a valgus-impacted four-part fracture and was initially treated by plate osteosynthesis; 19 months after the surgery, the patient requested removal of material, which was performed arthroscopically.Three weeks later, she suffered a joint infection that required multiple surgeries, leading to reverse shoulder arthroplasty.One case of early-onset infection in a 64-year-old female without relevant diseases in her medical history required multiple revision surgeries, which ultimately led to reverse shoulder arthroplasty.This is report 6 of 6 for (b)(4).This report is for an unknown synthes philos (malreduction, necrosis).

• Brand Name: UNK - CONSTRUCTS: PHILOS PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• 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: 14830232
• MDR Text Key: 295058301
• Report Number: 8030965-2022-04358
• Device Sequence Number: 1
• Product Code: HRS
• 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: 06/27/2022
• 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: 05/30/2022
• 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