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

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

Patient Problems Osteolysis (2377); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.It is unknown when condition began.This report is for quantity 1 for unknown radial stem.Device remains implanted in patient, device has not been explanted.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that a patient was implanted with a depuy synthes radial head prosthesis system on (b)(6) 2014.An x-ray on an unknown date revealed radiolucency around the implant and per the surgeon, showed osteolysis.The patient is not complaining of any pain and the implant remains intact.Patient status is unknown and there are no plans to explant the device.This report is for quantity 1 of unknown radial stem.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: device was used for treatment, not diagnosis.Osteolysis is a result of the complained event, not history.The 510(k) is unknown.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 USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6058206
• MDR Text Key: 58453561
• Report Number: 2520274-2016-15076
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• 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: 11/02/2016
• 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