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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 33680005
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Pain (1994); Osteolysis (2377); Swelling/ Edema (4577)
Event Date 07/21/2021
Event Type  Injury  
Manufacturer Narrative
The device remains implanted in the patient. If additional information becomes available, it will be provided on a supplemental report. Device remains implanted in patient.
 
Event Description
It was reported that the patient experienced a spontaneous increase in swelling and pain which was exacerbated 2 days later. The patient reports increased swelling is very apparent when showering. The surgeon obtained an xray of the foot which showed a medial malleolar stress fracture. Patient was placed in a fracture boot. Rice treatment. 8 days later it was reported that the patient was worsening. The patient notes increasing pain at the medial malleolus and fracture site, exacerbated by weight bearing. X-rays taken which show an abundant periosteal reaction about the medial malleolus fracture and increased lucency at fracture line. Total ankle prosthesis appears stable. Treatment options were discussed. Discussed observation with wbat in fracture boot vs nwb with crutches vs surgical treatment. The patient underwent an orif medial malleolus six days later. Adverse event is improving. 2 week follow-up of right medial malleolus stress fracture s/p orif medial malleolus. Patient had a right ankle replacement with deformity correction. Patient is doing well, making expected progress and pain is well-controlled.
 
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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 Key12568607
MDR Text Key274489944
Report Number0001043534-2021-00193
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181557
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 10/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number33680005
Device Lot Number1704629
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/07/2021
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: 10/04/2021 Patient Sequence Number: 1
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