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

Device Problem Unintended Movement (3026)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Date of event: date of postoperative implant loosening is unknown.This report is for one (1) unknown radial stem.Part and lot numbers are unknown.(therapy date): implanted approximately two (2) years ago.Explanted date: unknown.Complainant device is not expected to be returned for manufacturer review/investigation.(510k): unknown, as specific part and lot numbers for radial stem is not provided.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 underwent a left radial head prosthesis procedure on an unknown date, approximately two years ago.The patient attended physical therapy and took pain medications for four to six weeks postoperatively.She went back to see the surgeon, who stated that the arm was ¿usable¿.She was released by the surgeon in (b)(6) of 2016.The patient has experienced loss of strength in the left arm and wrist.She stated that she can feel the prosthesis in the arm, since she has lost weight.The patient also stated that she has experienced ongoing pain in the arm, which began approximately one year ago, from her elbow to her wrist.She has trouble using the arm when turning certain ways.Also, she has trouble sleeping on the elbow due to tenderness.The patient has a history of bilateral neuropathy in her feet.She presently takes pain medications norco/tylenol to treat the neuropathy, and also the pain in the left elbow.The patient is scheduled for a follow up appointment with her surgeon on (b)(6) 2017.Patient followed up with surgeon (b)(6) 2017 and it was confirmed by x-rays, that the radial stem has loosened in the intramedullary canal.The head was not loose and is fully intact with the stem.Surgeon stated that the radial stem needs to be removed.Concomitant devices reported: radial head (part # unknown, lot # unknown, quantity # 1) this report is for one (1) unknown radial stem.This is report 1 of 1 for complaint (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: 6593915
• MDR Text Key: 76051515
• Report Number: 2520274-2017-11716
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/01/2017
• 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 # UNKNOWN, LOT # UNKNOWN, QTY 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 72