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 Necrosis (1971); Loss of Range of Motion (2032); Non-union Bone Fracture (2369); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.There are multiple patients.All known information is provided in the literature article.This report is for an unknown philos plate and screw construct/unknown lot.Part and lot number are unknown; udi number is unknown.There are multiple unknown dates of implantation between 2011 and 2017.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr and manufacture date: 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: gavaskar, a.S.Et al.(2022), what factors are associated with poor shoulder function and serious complications after internal fixation of three-part and four-part proximal humerus fracture-dislocations?, clinical orthopaedics and related research, vol.00, pages 1-8 (india).Between 2011 and 2017, a total of 64 patients (27 males and 21 females with a mean age of 48 years +/ 15 years) with three-part or four-part proximal humerus fracture dislocations underwent fracture reduction and fixation using laterally positioned locked plates (philos, depuy-synthes).The following complications were reported: 12 patients had poor shoulder function or encountered serious complications.4 patients had nonunion: two of these patients underwent bone grafting.One patient successfully achieved fracture union after grafting.The remaining three patients underwent shoulder arthroplasty.10 patients had radiographic evidence of avn, six of whom underwent shoulder arthroplasty.Two patients who underwent arthroplasty had both avn and nonunion.A total of 7 patients underwent arthroplasty; hemiarthroplasty in three patients and reverse total shoulder arthroplasty in 4 patients.This report is for an unknown synthes philos plate/screw construct.This is report 1 of 1 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15116860
• MDR Text Key: 296759556
• Report Number: 8030965-2022-05305
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• 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: 06/29/2022
• 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