MAUDE Adverse Event Report: SYNTHES MONUMENT 10MM TI STRAIGHT RADIAL STEM 32MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 04.402.010S

Device Problem Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: date of event is unknown.(b)(4).Device remained implanted in the patient, thus explant date is not applicable.Device is not expected to be returned for manufacturer review/investigation, as device remained implanted in the patient.A device history record review was completed for part #04.402.010s, lot #7012269: release to warehouse date: 02-april-2013, expiration date: 28-feb-2018, supplier: (b)(4): no non-conformance reports (ncrs) were generated during production.Review of device history records showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.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 there is suspected loosening of a radial head prosthesis that was originally implanted on (b)(6) 2015.The surgeon is concerned that the implant seemed to be loosening as noticed on x-rays during the patient's recent visit to office.Further treatment has not been determined at this time.This is report 1 of 2 for (b)(4).

• Brand Name: 10MM TI STRAIGHT RADIAL STEM 32MM-STERILE
• 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: 6180618
• MDR Text Key: 62545838
• Report Number: 1719045-2016-10919
• 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
• Type of Report: Initial
• Report Date: 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 04.402.010S
• Device Lot Number: 7012269
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1