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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY ADAPTIS TOTAL ANKLE SYSTEM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

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WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY ADAPTIS TOTAL ANKLE SYSTEM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 33680021
Device Problem Migration (4003)
Patient Problems Failure of Implant (1924); Loss of Range of Motion (2032); Implant Pain (4561)
Event Date 08/04/2021
Event Type  Injury  
Manufacturer Narrative
Device remains implanted in the patient. If additional information becomes available, it will be provided on a supplemental report.
 
Event Description
It was reported that the prosthesis appears to have subsided anteriorly. Patient states that she has soreness at the medial and lateral aspect of her right ankle. She notes that she has cut back on formal pt, attending once weekly due to soreness. She notes her concerns about overworking her ankle. Patient notes that she only began aggressive exercises the last 2 to 4 times she has last been at pt. Prior to surgical treatment patient notes stiffness and limited rom of her ankle. However, she notes improvement of ankle rom.
 
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Brand NameINFINITY ADAPTIS 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 Key12418138
MDR Text Key270282783
Report Number0001043534-2021-00169
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172633
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number33680021
Device Lot Number1683232
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/29/2020
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: 09/02/2021 Patient Sequence Number: 1
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