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 Hematoma (1884); Unspecified Infection (1930); Nerve Damage (1979)

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.Event date unknown.This report is for an unknown philos plate/screw 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

This report is being filed after the review of the following journal article: ott, n.Et al.(2021), reverse shoulder arthroplasty for proximal humeral fractures: better clinical midterm outcome after primary reverse arthroplasty versus secondary reverse arthroplasty after failed orif in the elderly, seminars in arthroplasty, vol.31, pages 488-494 (germany).The the purpose of our study was to assess clinical outcomes after primary reverse total shoulder arthroplasty (rtsa) and compare the outcomes of primary versus secondary rtsa for proximal humeral fractures.From 2010 to 2015, a total of 57 patients who underwent primary rtsa (30) and secondary rtsa after the failure of plate osteosynthesis (27) after proximal humeral fractures.All patients received an unconstrained reverses shoulder prosthesis (deltaxtend/depuy/synthes, johnson & johnson medical gmbh, umkirch).The secondary group underwent rtsa after the failure of open reposition and internal fixation by using a locking plate (philos, depuy/synthes, johnson & johnson gmbh, umkirch).The average age of all patients was 76 years (min.55; max.94; sd 7).The following complications were reported as follows: philos.(n=2) periprosthetic infection.(n=1) hematoma.(n=1) nerve lesion.This is report 1 of 1 for (b)(4).This report is for an unknown synthes philos plate/screw construct.

• 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: 15116742
• MDR Text Key: 296760194
• Report Number: 8030965-2022-05303
• 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,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