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

Device Problem Unintended Movement (3026)

Patient Problems Fall (1848); Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Patient¿s weight is unknown.Date of postoperative pain and loosening of the device is unknown.This report is for one (1) unknown radial stem.Part and lot numbers are unknown.Without the specific part number, the udi is not available.Implanted approximately 2 years ago; exact date is unknown.Without a lot number, the device history record review could not be requested.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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 had original surgery approximately two (2) years ago, for treatment to the radial head bone.Patient was implanted with one (1) radial head implant and one (1) radial stem implant.On an unknown date, post-operatively, patient fell.Patient was experiencing postoperative pain prior to the fall, but did not seek treatment.After patient fell, the patient's pain level increased substantially, and the patient returned to the surgeon.X-rays taken on an unknown date showed a possible loosening of the implant, and a possible void at the stem of the implant.Patient was returned to the operating room on (b)(6) 2017 for explant and revision surgery.During the explant procedure, the surgeon noted that the prosthesis was loose and was manually removed without the use of instrumentation.It was also noted that the surface of the implant was rough 'like sandpaper'.Surgeon revised the patient to a biomet implant.No fragments were generated during implant removal.Revision surgery was completed successfully with no surgical delay.Patient is reported in stable condition.This report is for one (1) unknown radial stem.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

A returned unknown titanium straight radial stem and unknown radial head were reported to have been revised and explanted due to pain and postoperative loosening.This complaint condition has been investigated and resulted in recall and the voluntary product removal of the radial head prosthesis system.The issue has already been identified and appropriate actions have been taken to address the issue.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 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: 6789265
• MDR Text Key: 82574343
• Report Number: 1719045-2017-10756
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112030
• 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,Followup
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention