MAUDE Adverse Event Report: SMALL BONE INNOVATIONS, INC. RHEAD RECON RADIAL HEAD IMPLANT; PROSTHESIS,ELBOW,HEMI,RADIAL,POLYMER

Model Number 410-0009

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Arthritis (1723); Failure of Implant (1924); Fracture, Arm (2351)

Event Date 05/26/2009

Event Type  Injury  

Event Description

The rhead recon head implant from the uni-elbow radio capitellum system was revised to address the radial head loosening.

Manufacturer Narrative

Additional removed components: model#: rcn-s3.Surgery report was reviewed and no definitive conclusions could be made.

• Brand Name: RHEAD RECON RADIAL HEAD IMPLANT
• Type of Device: PROSTHESIS,ELBOW,HEMI,RADIAL,POLYMER
• Manufacturer (Section D): SMALL BONE INNOVATIONS, INC.; morrisville PA
• Manufacturer Contact: kevin ladd ; 1380 s. pennsylvania avenue; morrisville, PA 19067 ; 2153376436
• MDR Report Key: 3874017
• MDR Text Key: 20011990
• Report Number: 3003640913-2014-00041
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: K023604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/30/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 410-0009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR