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

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Patient age or date of birth and weight not available for reporting.Date of device loosening is not known.This report is for an unknown radial head prosthesis.Part and lot numbers are unknown; udi number is unknown.Complainant part 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 the patient underwent revision of a radial head prosthesis system on (b)(6) 2017 due to pain and loosening of the hardware (hardware failure).The hardware was originally implanted on (b)(6) 2016.This report is for one (1) unknown radial head prosthesis.This is report 1 of 2 for (b)(4).

• 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: 6860001
• MDR Text Key: 85907039
• Report Number: 1719045-2017-10902
• 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: other
• Reporter Occupation: Attorney
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• 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: 08/21/2017
• 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
• Patient Outcome(s): Required Intervention