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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ3 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ3 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 33680003
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Implant Pain (4561)
Event Date 10/17/2022
Event Type  Injury  
Event Description
It was reported that the patient underwent a total ankle replacement.The patient presented with nerve pain at the right ankle.The treatment involved the effected leg being placed in short leg cast, ice, elevate.Overall, patient is healing and doing well post-operatively.Treatment included medication and increased activity.Healing and progressing well postoperatively.Nerve pain should continue to improve.Treatment included medication and viscose pad for shoe.
 
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.
 
Manufacturer Narrative
The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection revealed the following: a device inspection was not possible since the affected device was not returned and no other evidences were provided 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.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.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.The patient presented with nerve pain at the right ankle.The treatment involved the effected leg being placed in short leg cast, ice, elevate.Overall, patient is healing and doing well post-operatively.Treatment included medication and increased activity.Healing and progressing well postoperatively.Nerve pain should continue to improve.Treatment included medication and viscose pad for shoe.
 
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Brand Name
INFINITY ADAPTIS TIB SZ3 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 Key17241445
MDR Text Key318265072
Report Number3010667733-2023-00365
Device Sequence Number1
Product Code HSN
UDI-Device Identifier00889797069656
UDI-Public00889797069656
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 Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number33680003
Device Catalogue Number33680003
Device Lot Number1690411
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/13/2020
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) Required Intervention;
Patient SexFemale
Patient Weight76 KG
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