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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
Model Number SEE H10
Device Problem Mechanical Problem (1384)
Patient Problem Pain (1994)
Event Date 11/02/2018
Event Type  Injury  
Manufacturer Narrative
The lot of the suspect device was not identified, therefore, the manufacturer cannot determine the suspect device.However, the suspect devices in use are part # 3650014, lot 1593472; part # 33630024, lot 1591710; and part # 33654406, lot unknown.Manufacture date for part # 3650014, lot 1593472 is 2/21/2017; manufacture date for 33630024, lot 1591710 is 05/24/2017.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 surgeon revised the infinity prosthesis as the patient was experiencing lateral pain.Ct scans showed hot spots around the prosthesis showing there to be impingement.Upon visual inspection of post op x-rays the implant according to both surgeons noted the implant to be too lateral.The surgical decision was to remove the original implant, resect more medial mal, and re-implant a size 4 long tibia, 4 talus and 6mm poly.
 
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Brand Name
INFINITY 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
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 Key8144129
MDR Text Key129791374
Report Number1043534-2018-00191
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K140749
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Physician
Type of Report Initial
Report Date 11/02/2018
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 No Information
Device Model NumberSEE H10
Device Lot NumberSEE H10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Hospital
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/07/2018
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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