• 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 FLAT CUT TALAR DOME SZ 2 INFINITY ADAPTIS; 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 FLAT CUT TALAR DOME SZ 2 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 33680032
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 12/21/2023
Event Type  Injury  
Event Description
The digital stryker prophecy team received a ct scan indicating that the patient underwent a a device explant surgery for reasons that are not available at the time of this report.
 
Manufacturer Narrative
The reported event could not 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 "there is a girdle-stone situation visible in the respective ct scan.There is no further information available in this case, but an infection is likely the cause for the removal of the implant.The initial implantation was in august 2023, therefore the infection is after less than 6 months and therefore there is a little chance, that the infection occurred as a result of the implantation.Without any more information on the case this cannot be assessed with certainty." 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.According to the medical assessment performed by the hcp, it was identified that there is a girdle-stone situation visible in the ct scan and hence infection can be the likely cause for the removal of the implant, also there is a little chance that the infection occurred as a result of the implantation, but without any further information on the case this cannot be assessed with certainty.If device is returned or any further information is provided, the investigation report will be reassessed.H3 other text : device disposition unknown.
 
Manufacturer Narrative
The reported event could not 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 "there is a girdle-stone situation visible in the respective ct scan.There is no further information available in this case, but an infection is likely the cause for the removal of the implant.The initial implantation was in august 2023, therefore the infection is after less than 6 months and therefore there is a little chance, that the infection occurred as a result of the implantation.Without any more information on the case this cannot be assessed with certainty." 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.According to the medical assessment performed by the hcp, it was identified that there is a girdle-stone situation visible in the ct scan and hence infection can be the likely cause for the removal of the implant, also there is a little chance that the infection occurred as a result of the implantation, but without any further information on the case this cannot be assessed with certainty.If device is returned or any further information is provided, the investigation report will be reassessed.
 
Event Description
The digital stryker prophecy team received a ct scan indicating that the patient underwent a a device explant surgery for reasons that are not available at the time of this report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FLAT CUT TALAR DOME SZ 2 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 Key18797949
MDR Text Key336446955
Report Number3010667733-2024-00118
Device Sequence Number1
Product Code HSN
UDI-Device Identifier00889797073066
UDI-Public00889797073066
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191393
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 05/16/2024
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 Catalogue Number33680032
Device Lot Number1743880
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/30/2024
Initial Date FDA Received02/28/2024
Supplement Dates Manufacturer Received04/23/2024
Supplement Dates FDA Received05/16/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/18/2022
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
-
-