MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. TOTAL ANKLE; SMALL JOINT COMPONENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Rash (2033); Swelling (2091); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

The investigation is not complete, additional information has been requested.This report will be updated when the investigation is complete, trends will be evaluated.

Event Description

Allegedly, patient is having a reaction, redness, swelling.Persistent rash began in february.Noticed redness postop and as treated for infection.Patient has itp.Right ankle.Further information provided 5/10/2016, no cement was used.Surgeon suggested nickel testing.Patch testing being performed to determine if patient has a reaction to ti, ni and some other metals.

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: TOTAL ANKLE
• 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: 5685785
• MDR Text Key: 46120070
• Report Number: 1043534-2016-00037
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2016
• Initial Date FDA Received: 05/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR