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

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

Patient Problems Pain (1994); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

This report is for one (1) unknown radial stem.Part and lot numbers are unknown.Without a valid part and lot number, the udi is not available.Complainant device is not expected to be returned for manufacturer review/investigation.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 a patient , who underwent a left radial head prosthesis implant procedure on (b)(6) 2015 after her left radial head ¿shattered¿ while horseback riding, has been experiencing wrist pain, radiating pain down her left arm and numbness since the surgery.She now wonders if these symptoms are related to the recalled implant.She stated that she had several follow-up visits with the surgeon after the procedure (unknown dates in 2016), and had multiple x-rays taken.There is no additional information available.This report is for one (1) unknown radial stem.This is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis statement.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: 6578516
• MDR Text Key: 75550478
• Report Number: 2520274-2017-11674
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• 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: N
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention