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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
Catalog Number UNK_WWA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 06/16/2021
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. 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 surgery. Allegedly, the patient underwent a revision surgery for a tal and the surgeon also did a poly swap during the procedure.
 
Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided. More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event. A health care professional reviewed the ct scans and wasn't able to give a assessment on the scans a review of the device history was not possible because the lot number was not communicated. No corrective actions are required at this time. A review of the labeling did not indicate any abnormalities. No indications of material, manufacturing or design related problems were found during the investigation. If the device is returned or if any additional information is provided, the investigation will be reassessed.
 
Event Description
It was reported that the patient underwent a total ankle replacement surgery. Allegedly, the patient underwent a revision surgery for a tal and the surgeon also did a poly swap during the procedure.
 
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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
MDR Report Key12163403
MDR Text Key261455334
Report Number0001043534-2021-00119
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
Type of Report Initial,Followup
Report Date 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_WWA
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/13/2021 Patient Sequence Number: 1
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