MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE TALAR DOME SZ 3 SULCUS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	220220903
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Cyst(s) (1800); Bone Fracture(s) (1870); Implant Pain (4561)
Date of Event	12/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.Device remains implanted in patient.
Event or Problem Description
It was reported that the patient underwent a total ankle replacement.The patient presented with pain.Upon ct scan, it was noted that the talar component appears to have subsided.The patient may need to undergo a revision surgery for the talar component and poly extraction.
Additional Manufacturer Narrative
The reported event could be confirmed, since review of the available information and provided ct imaging does confirm the talar component has subsided and the talar neck has fractured which most likely will require a revision surgery.Medical affairs was consulted on the details of this case.According to their review of the available information and the provided ct imaging, "the tibial components are all in the right position, no signs of loosening.The talar component has subsided anteriorly and cysts formation around the talar stem and anteriorly in the talus are visible.There is a fracture of the talar neck".Based on investigation, the root cause was attributed to a patient-factors related issue.The subsidence of the talar component was most likely caused by the presence of cysts in the talus as well as the fracture of the talar identified in the talar neck.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 more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that the patient underwent a total ankle replacement.The patient presented with pain.Upon ct scan, it was noted that the talar component appears to have subsided.The patient may need to undergo a revision surgery for the talar component and poly extraction.

• Brand Name: INBONE TALAR DOME SZ 3 SULCUS
• Common Device Name: 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 Key: 16188753
• Report Number: 3010667733-2023-00021
• Device Sequence Number: 12400284
• Product Code: HSN
• UDI-Device Identifier: 00840420124227
• UDI-Public: 00840420124227
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K100886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 220220903
• Device Catalogue Number: 220220903
• Device Lot Number: 1647858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/22/2022
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 04/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Unknown