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 Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.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: klug, a.Et al.(2019), complications after surgical treatment of proximal humerus fractures in the elderlydan analysis of complication patterns and risk factors for reverse shoulder arthroplasty and angular-stable plating, journal of shoulder and elbow surgery, vol.28, pages 1674-1684 (germany).To improve the preoperative decision making, the current study was designed to evaluate which surgical procedure (angular-stable plating or rtsa) leads to lower complication and revision rates and to determine possible independent risk factors in an elderly population.Between 2012 and 2017, 146 patients (aged 74.1 +/ 8.0 years) with complex proximal humerus fracture (phf) were treated with locking plates (open reduction-internal fixation [orif]) or reverse total shoulder arthroplasty (rtsa).There were 66 patients (45 females and 21 males) who were treated by angular-stable plating and 59 patients (53 females and 6 males) were treated with rtsa.Implants used were reverse shoulder prosthesis (delta xtend, depuy, warsaw, in, usa), the philos-plate (fa.Synthes, umkirch, germany) or the angular-stable k¿onigsee plate system (k¿onigsee implantate gmbh, allendorf, germany).There was a follow-up period of 1 year.The following complications were reported as follows: 4 cases had superior migration of the greater tuberosity with 1 case of complete loss of fixation and a subsequent varus collapse during the first year.17 patients had motion defects.4 patients had loss of fixation.1 patient had an infection.Staphylococcus epidermidis was successfully treated with a surgical debridement maintaining the hardware followed by a 4-week course.2 patients had a pulmonary embolism.1 patient had postoperative anemia.12.1% required a surgical revision, including early hardware removal and arthrolysis.4 cases had avascular necrosis of the humeral head.2 cases had avascular necrosis of the humeral head which were revised for associated screw perforation.A (b)(6) year-old woman (heavy smoker, body mass index: 54.7 kg/m2, osteoporosis) with a 4-part fracture of the proximal humerus after a bicycle accident.The fracture was initially fixed by a locking plate.However, a nonunion occurred after a follow-up of 8 months leading to a revision surgery with implantation of a hemiarthroplasty.Unfortunately, because of subluxation of the prosthesis with persisting motion deficits another revision surgery was performed after 3 months, including reverse shoulder arthroplasty.This report is for an unknown synthes philos-plating system.This is report 4 of 4 for (b)(4).

• 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: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12526809
• MDR Text Key: 273190551
• Report Number: 8030965-2021-08007
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• 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: 08/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR