MAUDE Adverse Event Report: SYNTHES MONUMENT 26MM COCR RADIAL HEAD STANDARD HEIGHT/13.5MM-STERILE; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Catalog Number 09.402.026S

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Pain (1994); Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).(b)(4).The subject device is not expected to be returned to the synthes manufacturer for evaluation.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.Sterility records for the reported lot/part number were also reviewed and determined to be conforming.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 experienced pain and underwent explant surgery on (b)(6) 2015 as a result of the loosening of the radial head and a titanium straight radial stem implant and osteolysis.The patient had begun to experience pain and x-rays taken on an unknown date had revealed osteolysis and loosening of hardware.During the surgery, a large amount of fluid was noted in the elbow and cultures were collected.The cultures came back negative for infection.The patient was not revised with new implants.There was no surgical delay reported and the procedure was completed successfully.The patient initially underwent an open reduction and internal fixation (orif) of the elbow on (b)(6) 2014.This report is 1 of 2 for (b)(4).

• Brand Name: 26MM COCR RADIAL HEAD STANDARD HEIGHT/13.5MM-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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5292807
• MDR Text Key: 33389910
• Report Number: 1719045-2015-10823
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK112030
• 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: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 09.402.026S
• Device Lot Number: 6892270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention