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U.S. Department of Health and Human Services

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

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WRIGHT MEDICAL TECHNOLOGY, INC. UNKNOWN PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative

Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes. 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

It was reported by the patient on a social media post that "i had an ankle fusion due to arthritis after i broke my ankle. It has been a nightmare. I became very ill and went into septic shock. My husband called an ambulance and i ended up in the hospital for 8 days. My doctor said i almost died. Horrible experience but i am still here!".

 
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Brand NameUNKNOWN
Type of DevicePROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington, tn
Manufacturer (Section G)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington, tn
Manufacturer Contact
matthew parrish
1023 cherry rd
memphis, tn 
MDR Report Key9954014
MDR Text Key188223032
Report Number1043534-2020-00078
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 CONSUMER
Type of Report Initial
Report Date 03/15/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/13/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2020
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? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/13/2020 Patient Sequence Number: 1
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