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U.S. Department of Health and Human Services

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

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WRIGHT MEDICAL TECHNOLOGY, INC. INBONE TOTAL ANKLE SYSTEM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Pain (1994); Swelling (2091)
Event Date 10/23/2019
Event Type  Injury  
Manufacturer Narrative
Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
 
Event Description
Allegedly, the patient underwent a total ankle replacement surgery. The patient report reported lots of swelling, pain, and nerve damage. The patient cannot leave foot down without swelling occurring and cannot walk barefoot anymore.
 
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Brand NameINBONE 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
matthew parrish
1023 cherry rd
memphis, TN 38117
MDR Report Key9354361
MDR Text Key167363257
Report Number1043534-2019-00195
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,consum
Type of Report Initial
Report Date 10/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/21/2019 Patient Sequence Number: 1
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