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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE TALAR DOME SZ 3 SULCUS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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WRIGHT MEDICAL TECHNOLOGY INC INBONE TALAR DOME SZ 3 SULCUS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 220220903
Device Problem Osseointegration Problem (3003)
Patient Problems Cyst(s) (1800); Loss of Range of Motion (2032); Inadequate Osseointegration (2646); Implant Pain (4561)
Event Date 11/22/2023
Event Type  Injury  
Event Description
The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery for reasons that are not available at the time of this report.The physician noted that the tibial component has subsided.The patient has continued pain and limited range of motion.
 
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 reported event could not be confirmed due to the lack of additional clinical information.Upon further investigation of the ct scans by healthcare professionals the following was observed: ¿the talus shows a little bit of cysts posteriorly, there is no clear radiolucence as an indicator for loosening.There is a potential loosening or subsidence, here-but that could be better visible with the comparison of x-rays directly after the implantation and the latest x-rays.The surgeon assumes that the components could be loose.This cannot be confirmed with certainty using the ct images.As a certain amount of pain and restricted movement are described as the main clinical symptoms, i believe that a soft tissue problem could also be the cause of the pain/reduced range of motion.¿ 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 the device is returned or if any additional information is provided, the investigation will be reassessed.
 
Event Description
The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery for reasons that are not available at the time of this report.The physician noted that the tibial component has subsided.The patient has continued pain and limited range of motion.
 
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Brand Name
INBONE TALAR DOME SZ 3 SULCUS
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 Key18347810
MDR Text Key330807130
Report Number3010667733-2023-00787
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100886
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 02/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue Number220220903
Device Lot Number1670794
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/25/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/15/2020
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 SexMale
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