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

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

Patient Problems Bone Fracture(s) (1870); Necrosis (1971); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - constructs: philos plate/screws/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 conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 (b)(6) as follows: this report is being filed after the review of the following journal article: porschke, f.; bockmeyer, j.;nolte, p.-c.; studier-fischer, s.; guehring, t.; schnetzke, m.(2021), more adverse events after osteosyntheses compared to arthroplasty in geriatric proximal humeral fractures involving anatomical neck, journal of clinical medicine, volume 10, 979, pages 1-11, (germany).The purpose of this study was to compare adverse events and clinical outcomes of geriatric proximal humerus fractures (phf) involving the anatomical neck (type c according to ao classification) treated with open reduction and internal fixation (orif) using locking plate vs.Arthroplasty.Between january 2008 and october 2014, 59 geriatric patients (mean age: 75.3 +/- 5.5 years) who underwent operative treatment using orif or arthroplasty for type c phfs were included in the study.Depending on the severity of the fracture and patient factors (e.G., comorbidities, preference of the patient) osteosynthesis using an unknown synthes proximal humeral locking-plate (philos) or arthroplasty (hemiarthroplasty: global fx shoulder fracture system; reversed total shoulder arthroplasty: delta xtend system) was chosen for treatment.A total of 31 patients (24 males and 7 females with a mean age of 74.1+/-3.7 years were implanted with an unknown synthes philos plates.Postoperatively, the shoulder was immobilized in a sling.If the tuberosities were repaired, a shoulder abduction pillow at 30 degrees was used after 2 days.Passive range- of-motion exercises started within 2 days after surgery up to 90 degrees of abduction/ flexion and limited to 20 degrees of external rotation (if the tuberosities were repaired).This was followed by active-assisted range-of-motion exercises at 3 weeks and unrestricted, active range-of-motion and strengthening exercises at 7 weeks postoperatively.Complications were reported: 6 patients had humeral head necrosis and were revised with arthroplasty.3 patients had a simultaneous infection and were therefore revised utilizing a two-stage protocol (first surgery: hardware removal, humeral head resection and antibiotic cement spacer implantation; second surgery: arthroplasty).1 patient had posttraumatic omarthritis.1 patient had pseudarthrosis.1 patient had periosteosynthetic fracture.1 patient had rotator cuff deficiency.1 patient underwent reosteosynthesis.8 patients required elective hardware removal.2 patients had intraarticular screw and underwent singular screw removal.8 patients died and were excluded from the study.The cause of death was not mentioned in the article.This report is for the unknown synthes proximal humerus internal locking system plate (philos).This report is for (1) unk ¿ plates.This report is 1 of 2 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PHILOS PLATE/SCREWS
• Type of Device: SCREW,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: 11987096
• MDR Text Key: 262436984
• Report Number: 8030965-2021-04864
• 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: Physician
• Type of Report: Initial
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• 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: 05/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention