MAUDE Adverse Event Report: SMALL BONE INNOVATIONS/ STRYKER/ MILLSTONE MEDICAL RHEAD, RADIAL IMPLANT, STANDARD STEM, SIZE 2

Model Number RHA-S2

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 01/14/2017

Event Type  Injury  

Event Description

Five months post left radial head arthroplasty for communited radial head fracture i developed increasing pain and loss range of motion.Surgeons findings that i had a grossly radial head implant when i am weight bearing of the renal stem.I had close to zero pronation and supination and lacking 20 degrees extension.X-rays and revision surgery concluded these findings.Revision surgery was needed 5 months after initial surgery and again 10 months after the first version.This has been a total of 3 surgeries in just about one year.

• Brand Name: RHEAD, RADIAL IMPLANT, STANDARD STEM, SIZE 2
• Type of Device: RHEAD, RADIAL IMPLANT, STANDARD STEM, SIZE 2
• Manufacturer (Section D): SMALL BONE INNOVATIONS/ STRYKER/ MILLSTONE MEDICAL
• MDR Report Key: 7027283
• MDR Text Key: 92142686
• Report Number: MW5073265
• Device Sequence Number: 2
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/09/2017
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: RHA-S2
• Device Catalogue Number: RHA-S2
• Device Lot Number: 9884-601E
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Weight: 48