MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. EVOLVE(R) RADIAL HEAD; SMALL JOINT COMPONENT

Catalog Number 496-HXXX

Device Problem Device Slipped (1584)

Patient Problems Fall (1848); Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

Event Description

It was reported per moghaddam et al "outcome of radial head arthroplasty in comminuted radial head fractures: short and midterm results", that eighty-five patients with comminuted radial head fractures and associated injuries received treatment with prosthesis between may 2001 and november 2009.Seventy-five patients were available for follow-up.On average, patients were followed for 41.5 months.The following complications were documented; three revisions were reported from the original group of patients.One revision was due to disconnection of the head from the stem.This was resolved with revision and a prosthesis.Two revisions were due to loosening of the prosthesis and persistent pain.One of these two was treated by removal.It is unclear how the other patient with pain and loosening was resolved.There were three additional removals reported; two were due to periprosthetic lucency with persistent pain and one was due to loosening caused by a traumatic fall.

Manufacturer Narrative

This incident is considered closed.If at any time new or updated information becomes available, the incident will be re-opened and investigated.

• Brand Name: EVOLVE(R) RADIAL HEAD
• Type of Device: SMALL JOINT COMPONENT
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: 1023 cherry road; memphis, TN 38117 ; 901290-566
• MDR Report Key: 5548389
• MDR Text Key: 41913515
• Report Number: 1043534-2016-00021
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: K030384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 496-HXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/15/2016
• Event Location: Other
• 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