MAUDE Adverse Event Report: SYNTHES MONUMENT; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

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

Patient Problems Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not for diagnosis.Sullivan, m; et al (2017) radial neck dilatory remodeling after radial head arthroplasty with an uncemented, press fit, fully chemically etched stem design.J orthop trauma 31:9, 497-502.This report is for an unknown radial head system (unknown quantity/unknown lot).(other number) udi: unknown part number, udi is unavailable.The investigation could not be completed; no conclusion could be drawn, as no device was returned and no lot number or part number was provided.(b)(4).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 subsequent review of the following literature article: sullivan, m; et al (2017) radial neck dilatory remodeling after radial head arthroplasty with an uncemented, press fit, fully chemically etched stem design.J orthop trauma 31:9, 497-502.This is a retrospective study to compare radiographic outcomes of 2 widely used side loading, press fit radial head implants to reconstruct complex elbow trauma.From 2007 to 2015, 85 subjects underwent radial head arthroplasty (rha) and met inclusion criteria.There were 63 subjects in the partially coated rha (biomet); 19 subject in the fully chemically etched rha (synthes radial head prosthesis system) and 3 subjects in the end loading rha (avanta).Radial neck dilatory remodeling was defined as cortical thinning and expansion of the radial neck to a greater diameter.Stress shielding was identified as radiographic loss of proximal radial neck bone stock in the setting of a well-fixed stem and absence of periprosthetic lucency.The average calculated percentage of remodeling in the partially coated rha (biomet) group was 2.7% and fully etched rha (synthes) group was 34.9 percent.This difference in percentage of dilatory remodeling by group was statistically significantly different.Stress shielding occurred in 21/63 subjects in the partially coated rha group (biomet) and in 2/19 subjects in the fully etched rha group (synthes).Two subjects from the fully etched rha group (both revised for mechanical symptoms; catching, popping, and locking).Average time from index procedure to revision procedure was 13 months.The loosening and dilation associated with the fully etched stem design is also associated with an extreme degree of cortical thinning.A copy of the articles will be submitted with the medwatch.This is 1 of 1 for (b)(4).This report is for an unknown radial head system and refers to the serious injury of unknown patients who experienced radial neck remodeling and revision.

Manufacturer Narrative

Complaint was reviewed and determined to be a part of recall.Corrected data: 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.

• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6883731
• MDR Text Key: 87199463
• Report Number: 2520274-2017-12315
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• 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?: No
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention