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

Model Number 410-0006

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Arthritis (1723); Osteolysis (2377)

Event Type  Injury  

Event Description

Apparent loosening of the rhead radial steam implant and axial rotation from the uni-elbow radio capitellum system was reported.A malfunction of this type will most likely require a revision surgery.

Manufacturer Narrative

Additional removed components: model #: rha-s4.Surgery report and patient films were reviewed and indicate that the implant loosening was due to improper procedure at primary surgery.

• Brand Name: RHEAD; RHEAD 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: 3874027
• MDR Text Key: 20713424
• Report Number: 3003640913-2014-00044
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K011819
• 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: 410-0006
• 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): Other
• Patient Age: 54 YR