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

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient information not available for reporting.Udi: (01) part number unknown, (10) lot number unknown, udi unavailable.This report is for unknown unk - radial stem/unknown lot number.Original implant date is unknown.Device is not expected to be returned for manufacturer review/investigation.It was reported that the radial stem was loosening postoperatively which required removal.No new hardware was implanted.Without a lot number, the device history record review and 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 patient went through radial head prosthesis on unknown date.On unknown date, patient had removal of radial head prosthesis revision surgery due to stem loosening post operatively.Radial head and stem were removed without delay.New longer length radial stem and new radial head were implanted.Procedure was completed successfully.Patient is reported as stable.This complaint involves one device.This event is for third patient.The events for patient 1 and 2 are covered under (b)(4) respectively.Concomitant devices reported: radial head (part # unknown, lot # unknown, quantity # 1).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

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 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: 6063875
• MDR Text Key: 58657030
• Report Number: 2520274-2016-15111
• 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: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• 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?: No
• Date Manufacturer Received: 10/28/2016
• 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
• Treatment: RADIAL HEAD PART # UKN, LOT # UKN, QIY. 1
• Patient Outcome(s): Required Intervention