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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 Device-Device Incompatibility (2919)
Patient Problems Bone Fracture(s) (1870); Pain (1994)
Event Date 01/07/2020
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.During the surgery the surgeon had difficulty due to a possible tibia fracture.The surgeon utilized screw fixation.It was reported the patient may need to undergo a revision surgery.
 
Manufacturer Narrative
Review of the images confirms inbone stems and tibial base and what appears to be an invision talar dome.There also appears to be the two screws the surgeon used to correct the intraoperative bone fracture.
 
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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 38002
MDR Report Key9665103
MDR Text Key177639917
Report Number1043534-2020-00026
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,health
Type of Report Initial,Followup
Report Date 01/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/07/2020
Initial Date FDA Received02/04/2020
Supplement Dates Manufacturer Received01/07/2020
Supplement Dates FDA Received07/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age68 YR
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