MAUDE Adverse Event Report: SYNTHES MONUMENT 24MM COCR RADIAL HEAD STANDARD HEIGHT/13.0MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 09.402.024S

Device Problem Unintended Movement (3026)

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

Event Type  Injury  

Manufacturer Narrative

Patient weight is unknown.Udi: (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Part 09.402.024s, lot 7654220: release to warehouse date: october 14, 2014.Expiration date: september 30, 2019.Manufactured by: (b)(4), packaged by: (b)(4).No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.Sterility documentation was reviewed and determined to be conforming.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 implanted on (b)(6) 2016 with a 24mm radial head and 9mm straight radial stem.On an unknown date the patient returned to the surgeon complaining of lateral elbow pain.X-ray taken showed that the implant had migrated nearly out of the bone laterally.Revision surgery took place on (b)(6) 2016; the radial head and stem were removed.The canal was re-established with a 2.5 drill bit, a 30cc of cancellous bone graft was placed in the void.The surgery was completed with no reported delay.The patient's outcome was stable following the surgery; however, the patient's elbow will remain unstable permanently.The provided x-rays were reviewed by the manufacturer and it was noted that radiolucency around the implant stem could be seen.This is report 2 of 2 for (b)(4).

• Brand Name: 24MM COCR RADIAL HEAD STANDARD HEIGHT/13.0MM-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: 6186132
• MDR Text Key: 62742379
• Report Number: 1719045-2016-10930
• 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: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 09.402.024S
• Device Lot Number: 7654220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention