MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: PHILOS; PLATE, FIXATION ,BONE

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

Patient Problems Necrosis (1971); Malunion of Bone (4529); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: lanzetti, r.M.Et al (2023), reverse total shoulder arthroplasty demonstrates better outcomes than angular stable plate in the treatment of three-part and four-part proximal humerus fractures in patients older than 70 years, clinical orthopaedics and related research, vol.481 (xx), pages 735-747 (italy).The aim of this study was to sought to answer the following research questions: (1) in patients older than 70 years with three-part and four-part proximal humerus fractures, does rtsa result in better functional outcome scores (constant, american shoulder and elbow surgeons [ases], and dash scores) than orif with a locking plate? (2) does rtsa result in greater rom than orif? (3) does rtsa result in a lower risk of complications than orif? (4) in patients with either procedure, what are the rates of negative radiographic outcomes in those treated with orif (such as malunion, bone resorption, malalignment, or avascular necrosis) or those with rtsa (such as resorption, notching, and loosening)? (5) at a minimum of 2 years of follow-up, does orif result in a greater number of revision procedures than rtsa? between january 1, 2013 and june 20, 2018, patients who were treated surgically for a proximal humeral fracture at an urban trauma hospital were included: 81 patients were treated with reverse total shoulder arthroplasty (rtsa) and another 81 patients were treated with open reduction and internal fixation (orif).Orif was performed using the philos angular stable plate while rtsa was performed using a competitor device.Among the 81 patients treated with rtsa, 11% (nine patients) were lost to the minimum study follow-up of 2 years or had incomplete datasets, leaving 89% (72 patients; 32 male and 40 female; mean age was 76 ± 2.9 years) for analysis.Among the 81 patients treated with orif, 19% (15 patients) were lost before the minimal study follow-up of 2 years or had incomplete datasets, leaving 82% (66 patients; 37 male and 29 female; mean age was 73 ± 2.9 years) for analysis.The median follow-up for both groups was 53 months (range 24 to 72 months).The following complications were reported as follows: orif group: 2 patients had adhesive capsulitis.1 patient experienced avascular necrosis of the humeral head.5 patients had varus malunions and 4 of them went to received rtsa and 1 opted for nonoperative treatment.4 patients had resorption of the greater tuberosity and 1 of them underwent revision.This report is for an unknown synthes philos plate.A copy of the literature article is being submitted with this report.This is report 1 of 2 for (b)(4).

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.G4-510k: this report is for an unknown plates: philos/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H6: 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.

• Brand Name: UNK - PLATES: PHILOS
• 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: 19125270
• MDR Text Key: 340449562
• Report Number: 8030965-2024-05200
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

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: 04/06/2024
• Initial Date FDA Received: 04/17/2024
• 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