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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Device Problem Migration (4003)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
The products were not returned for evaluation.Radiographic images were provided.Review of the images indicates infinity devices in-situ.However, based on the provided images alone, a conclusion cannot be drawn as to why the revision is being performed.
 
Event Description
It was reported that the patient underwent a total ankle replacement surgery.Allegedly, the patient will need to undergo a revision surgery due to subsidence of the tibia.
 
Manufacturer Narrative
Additional info h10: h6: the products were not returned for evaluation.Radiographic images were provided.Evaluation of the images does appear to show the tibial tray has subsided.There is also lucency around the anterior peg of the tibial tray.
 
Event Description
It was reported that the patient underwent a total ankle replacement surgery.Allegedly, the patient will need to undergo a revision surgery due to subsidence of the tibia.
 
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Brand Name
INFINITY TOTAL ANKLE SYSTEM
Type of Device
PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
MDR Report Key11345022
MDR Text Key232439013
Report Number1043534-2021-00027
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received01/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
POLY; POLY; TALUS; TALUS; TIBIA IMPLANT; TIBIA IMPLANT; POLY; TALUS; TIBIA IMPLANT
Patient Outcome(s) Required Intervention;
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