MAUDE Adverse Event Report: SYNTHES MONUMENT 20MM COCR RADIAL HEAD STANDARD HEIGHT/12.0MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 09.402.020S

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device is not expected to be returned for manufacturer review/investigation.Patient code (b)(4) reported as the patient had to return to the or for a revision of the implant which they removed it and replaced it.A device history record review was performed on part 09.402.020s, lot #7838260: release to warehouse date: 09-feb-2015, expiration date: 12/2019, supplier: (b)(4).No non conformance reports (ncrs) were generated during production; review of the device history record(s) 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 a patient was initially implanted with the radial head prosthesis system on (b)(6) 2015.The patient was brought back to the operating room three days later on (b)(6) 2015 for a revision of the initial implants due to instability.It was reported that the joint was overstuffed and therefore, the surgeon put in smaller devices and also performed an ulna ligament repair.No additional information is available regarding this surgery.Patient underwent a total of five surgeries.This report addresses the first revision surgery held on (b)(6) 2015 due to instability.The surgery, which took place on (b)(6) 2015 to place an external fixator, has been captured under linked complaint (b)(4) also the hardware removal which took place on (b)(6) 2016 as implants remained loose has been captured under linked complaint (b)(4).This report is for one (1) 20mm cocr radial head standard height/12.0mm-sterile.This is report 1 of 2 for (b)(4).

• Brand Name: 20MM COCR RADIAL HEAD STANDARD HEIGHT/12.0MM-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: 6371770
• MDR Text Key: 68780930
• Report Number: 1719045-2017-10169
• 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: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 09.402.020S
• Device Lot Number: 7838260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2017
• Initial Date FDA Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention