MAUDE Adverse Event Report: SYNTHES USA 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 Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

This device was used for treatment, not diagnosis.Date of event: unknown.(b)(4) lot number unknown.Explant date: unknown.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.An image reading of the x-rays was conducted by a medical director from this manufacturer.The medical director says, it appears there is a relative low density zone around the implant but cannot comment too much due to lack of quality and information.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 patient was implanted with radial head prosthesis system on (b)(6) 2015 for a radial head fracture.Postoperatively, after around 4-5 months, x-rays were taken on an unknown date and it was discovered that the construct had loosened in the radial medullary canal.The revision surgery was performed on an unknown date.The patient's outcome is unknown and it is unknown if the patient was treated with a new construct.This report is 2 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 USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5682455
• MDR Text Key: 46018551
• Report Number: 2520274-2016-12885
• 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: 05/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09.402.020S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/06/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR