Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 33650003
Device Problem Loss of Osseointegration (2408)
Patient Problem Insufficient Information (4580)
Event Date 04/28/2021
Event Type  Injury  
Manufacturer Narrative
Device not returned at time of this report.If additional information becomes available, it will be provided on a supplemental report.
 
Event Description
It was reported in a patient study that the patient had a surgical intervention due to the tibia implant loosening.The talus implant was solid clinically and radiographically, excellent remaining bone stock, no sign of infection, tibia 5% valgus & reluctant gutter impingement forefoot reasonably balanced.The patient was revised to a different tibia and the poly was also changed during the surgery.Talus remained from original surgery.No other information available.
 
Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.The devices had been implanted for approximately 2.5 years.There was no sign of infection.The patient's tibia was 5% valgus and had reluctant gutter impingement forefoot, reasonably balanced.The patient had a bmi greater than 30.There are many clinical factors that can affect the results of any surgery, such as surgical technique, pre-operative and post-operative care, the implant, patient pathology and daily activity.According to the current ifu provided with these devices, "dislocation and subluxation of prosthetic components can result from improper positioning and/ or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.Prosthetic components can loosen or migrate due to trauma or loss of fixation." 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 review of the device history for the reported lot did not indicate any abnormalities.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 more information is provided, the case will be reassessed.H3 other text: device discarded.
 
Event Description
It was reported in a patient study that the patient had a surgical intervention due to the tibia implant loosening.The talus implant was solid clinically and radiographically, excellent remaining bone stock, no sign of infection, tibia 5% valgus & reluctant gutter impingement forefoot reasonably balanced.The patient was revised to a different tibia and the poly was also changed during the surgery.Talus remained from original surgery.No other information available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
MDR Report Key11942375
MDR Text Key254538603
Report Number0001043534-2021-00095
Device Sequence Number1
Product Code HSN
UDI-Device Identifier00840420122506
UDI-Public00840420122506
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
Type of Report Initial,Followup
Report Date 09/17/2021
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 Lay User/Patient
Device Model Number33650003
Device Catalogue Number33650003
Device Lot Number1622487
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/11/2021
Initial Date FDA Received06/04/2021
Supplement Dates Manufacturer Received09/10/2021
Supplement Dates FDA Received09/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age60 YR
Patient Weight74
-
-