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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INFINITY¿ TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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INFINITY¿ TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number UNK_WWA
Device Problem Migration (4003)
Patient Problem Pain (1994)
Event Date 07/07/2021
Event Type  Injury  
Manufacturer Narrative
Device not returned at time of this report as it is still implanted.If additional information becomes available, it will be provided on a supplemental report.
 
Event Description
It was reported that the patient underwent a total ankle replacement surgical procedure.Sometime post-op it was found that the patient will need to undergo a revision surgery due to the tibia implant being ~9° varus to the mechanical axis.The patient has medial mal pain.
 
Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event (such as the reason for the revision) must be available in order to determine the root cause of the complaint event.A health care profession reviewed the ct scans and wasn't able to give a assessment on the scans.A review of the device history was not possible because the lot number was not communicated.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
 
Event Description
It was reported that the patient underwent a total ankle replacement surgical procedure.Sometime post-op it was found that the patient will need to undergo a revision surgery due to the tibia implant being ~9° varus to the mechanical axis.The patient has medial mal pain.
 
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Brand Name
INFINITY¿ TOTAL ANKLE SYSTEM
Type of Device
PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
MDR Report Key12267090
MDR Text Key264737385
Report Number0001043534-2021-00129
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
Type of Report Initial,Followup
Report Date 11/04/2021
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 Catalogue NumberUNK_WWA
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/07/2021
Initial Date FDA Received08/03/2021
Supplement Dates Manufacturer Received10/08/2021
Supplement Dates FDA Received11/04/2021
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;
Patient Age36 YR
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