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

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown radial stem/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation, as the device was reportedly discarded.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.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

It was reported, that there was a revision surgery performed on (b)(6) 2016 for explant of a radial head prosthesis and radial stem due to loosening of the radial stem within the left radial canal.The loosening of the radial stem was discovered during routine follow-up x-rays.There was no allegation against the radial head and it was functioning as intended.The patient was noted to be having minimal pain.The implant was removed successfully and the patient outcome was good.There was no surgical delay.Original implant date is unknown.This report is for an unknown radial stem.This is report 1 of 1 for (b)(4).

• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5504989
• MDR Text Key: 40498613
• Report Number: 2520274-2016-11679
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/01/2016

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2016
• Initial Date FDA Received: 03/16/2016
• 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