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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY TIBIAL TRAY SIZE 5 TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

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WRIGHT MEDICAL TECHNOLOGY INC INFINITY TIBIAL TRAY SIZE 5 TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 33650005
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 02/28/2022
Event Type  Injury  
Event Description
It was reported that the patient underwent a total ankle replacement revision procedure for reasons that are not available at the time of this report.
 
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: visual examination of the returned poly finds the removal tool still remains inside the poly.It appears the tool has been cut.There is damage to the lock detail consistent with removal techniques.The dovetail feature also has bilateral damage.Visual examination of the articulating surface of the poly finds wear consistent with contact with the talar dome.Visual examination of the talar dome finds scratches and evidence of articulation with the poly.There is evidence of bone cement around one of the pegs.There are also chisel marks on the peg with the bone cement and in multiple locations on the inferior side of the talar dome, consistent with damage caused during removal.Visual examination of the tibial tray finds most of the superior side covered with bone cement.There are chisel marks on all three pegs and scratches on the anterior side which are consistent with damaged caused during removal.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿improper selection, placement, positioning, and fixation of the prosthetic components may result in unusual stress conditions and a subsequent reduction in service life of the prosthetic component.Periodic, long-term follow-up is recommended to monitor the position and state of the prosthetic components, as well as the condition of the adjoining bone.¿.Formal medical opinion was sought from an experienced independent medical expert as below; ¿the prophecy report on case 63581 clearly shows subsidence of the talar component indicating loosening.It looks like the primary implantation of the infinity tar was done well.The amount of subsidence/loosening justifies a revision to prevent unnecessary further bone loss and deformation of the tibia, from an orthopedic surgical standpoint of view.I have no information to make such an assessment from a medical point of view.Without any further clinical information, i cannot assess any medical factors any further.¿.More detailed information about the complaint event such as clinical information must be available to determine the root cause of the complaint event.If any further information is provided, the complaint report will be updated.
 
Event Description
It was reported that the patient underwent a total ankle replacement revision procedure for reasons that are not available at the time of this report.
 
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Brand Name
INFINITY TIBIAL TRAY SIZE 5 TOTAL ANKLE SYSTEM
Type of Device
PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY INC
1023 cherry rd
memphis TN 38117
Manufacturer (Section G)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key14639240
MDR Text Key294290415
Report Number3010667733-2022-00201
Device Sequence Number1
Product Code HSN
UDI-Device Identifier00840420122520
UDI-Public00840420122520
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140749
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/13/2022
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? No
Device Operator Lay User/Patient
Device Model Number33650005
Device Catalogue Number33650005
Device Lot Number1622486
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2022
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/13/2022
Initial Date FDA Received06/08/2022
Supplement Dates Manufacturer Received06/16/2022
Supplement Dates FDA Received07/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/14/2018
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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