MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INBONE(R) TALAR STEM; SMALL JOINT COMPONENT

Catalog Number 20034790X

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 05/30/2016

Event Type  malfunction  

Manufacturer Narrative

This is a reportable malfunction.No revision surgery has occurred to date.The investigation is not complete.Trends will be evaluated.This report will be updated when the investigation is complete.This is the same event as 1043534-2016-00054, 00055, 00056, 00057, 00058, 00060.

Event Description

Allegedly, the patient had a total ankle replacement.Her surgery was in (b)(6) 2012.She continued to have periodic pain with her ankle but was able to manage and walk.However, the pain has grown intense and instead of frequently, it is all the time.She has visited her surgeon and he has given her shots and injections to calm the pain but nothing has helped, if anything it has become worse.From her x-rays he has determined that the insert in her bone in her leg is moving causing friction and probably the greatest amount of her pain.

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: INBONE(R) TALAR STEM
• 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 ; 901451-631
• MDR Report Key: 5756727
• MDR Text Key: 49132430
• Report Number: 1043534-2016-00059
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 20034790X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1