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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 Patient-Device Incompatibility (2682)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 05/08/2020
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
It was reported that the patient underwent a total ankle replacement surgery.Allegedly, the patient will undergo a revision surgery due to the talus component being slightly oversized and causing impinging.
 
Manufacturer Narrative
Additional info: h10: the product was not returned for evaluation; however, images were provided that do show inbone devices in-situ as well has multiple screws extending from the talus into the calcaneal bone.There is distortion in the images that make it difficult to confirm the allegation.
 
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Brand Name
INBONE TOTAL ANKLE SYSTEM
Type of Device
PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington, tn
MDR Report Key10122897
MDR Text Key194122198
Report Number1043534-2020-00118
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
PMA/PMN Number
K140749
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received05/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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