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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ1 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ1 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 33680001
Device Problems Osseointegration Problem (3003); Migration (4003)
Patient Problems Cyst(s) (1800); Inadequate Osseointegration (2646); Implant Pain (4561)
Event Date 09/21/2023
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.H3 other text : device remains implanted in patient.
 
Event Description
It was reported that the patient presented in the clinic with pain.Upon x-rays it was noted that the tibial component was loose.The patient will be undergoing a revision surgery to use a stemmed implant to correct the loosening.The physician definitely plans on revising the tibial component and will likely need to revise the talar component and well.
 
Event Description
It was reported that the patient presented in the clinic with pain.Upon x-rays it was noted that the tibial component was loose.The patient will be undergoing a revision surgery to use a stemmed implant to correct the loosening.The physician definitely plans on revising the tibial component and will likely need to revise the talar component and well.
 
Manufacturer Narrative
Correction: h6 device code.The reported event could be confirmed based on available medical record and medical expert assessment.The device inspection was not possible as the product was not returned for investigation.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.Upon further investigation of the ct scans by healthcare professionals the following was observed ¿the ct-scan shows that the tibial component is possibly loose and has subsided anteriorly.Cyst formation posteriorly.The talar component is well-fixed.No significant bone changes.Treating hcp has ruled out infection.¿ based on investigation, the root cause was attributed to a patient related issue.Cysts present around the tibial component change the physiology resulting in change in implant¿s orientation and contributed to failure.If device is returned or any further information is provided, the investigation report will be reassessed.
 
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Brand Name
INFINITY ADAPTIS TIB SZ1 INFINITY ADAPTIS
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 Key17953984
MDR Text Key325896795
Report Number3010667733-2023-00604
Device Sequence Number1
Product Code HSN
UDI-Device Identifier00889797069632
UDI-Public00889797069632
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181557
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue Number33680001
Device Lot Number1697042
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/07/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/20/2020
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) Other;
Patient Age54 YR
Patient SexFemale
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