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

Device Problems Unintended Movement (3026); Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Patient identifier, age or date of birth, and weight are not available for reporting.Date of device loosening is not known.This report is for an unknown radial stem.Part and lot numbers are unknown; udi number is unknown.Date of implant is not known.Device was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant device therapy date is not known.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.(b)(4).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 the patient experienced pain due to loosening of the radial head prosthesis.The patient was originally implanted on an unknown date; on an unknown date postoperatively, the device was discovered to be loose in the medullary canal.The surgeon does not think the head is loose from the stem.The surgeon is planning to schedule removal of the implant.Concomitant device reported: radial head (quantity 1).This report is for one (1) 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6597857
• MDR Text Key: 76176644
• Report Number: 2520274-2017-11743
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• 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: 05/03/2017
• 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
• Treatment: RADIAL HEAD (PART AND LOT UNKNOWN, QTY 1)
• Patient Outcome(s): Required Intervention