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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
Model Number 33650005
Device Problem Loss of Osseointegration (2408)
Patient Problem Failure of Implant (1924)
Event Date 05/04/2021
Event Type  Injury  
Manufacturer Narrative
Device remains implanted at the time of this report. If additional information becomes available, it will be provided on a supplemental report.
 
Event Description
It was reported that the patient underwent a total ankle replacement surgical procedure. It was reported that the patient had aseptic loosening of the tibial tray and will need a revision surgery.
 
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Brand NameINFINITY¿ TOTAL ANKLE SYSTEM
Type of DevicePROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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
nathe hendricks
1023 cherry rd
memphis, TN 38117
9014516318
MDR Report Key11891250
MDR Text Key252888825
Report Number0001043534-2021-00092
Device Sequence Number1
Product Code HSN
UDI-Device Identifier00840420122520
UDI-Public00840420122520
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K140749
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number33650005
Device Catalogue Number33650005
Device Lot Number1634347
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/13/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/26/2021 Patient Sequence Number: 1
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