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 Codes	Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); Inadequate Osseointegration (2646)
Date of Event	05/22/2023
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.H3 other text : device remains implanted in patient.
Event or Problem Description
It was reported that the patient underwent a total ankle replacement.Allegedly, the patient may need to undergo a revision surgery for subsidence in both tibia and talar component.Patient ankle progressively deforming into valgus.Given the stj fusion, the talar/calc block is everting at the ankle joint.The physician is also planning on stabilizing medial ankle with some sort of deltoid repair/augmentation.
Additional Manufacturer Narrative
The reported event could be confirmed, based on available medical record and health care professionals.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.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 tibial and the talar component do show clear signs of loosening (radiolucence and cavities) and migration tibial anterior and medial proximal, and the talar component shows subsidence laterally.Pe cannot be assessed directly, but can be assumed, that it has migrated together with the tibial component.Infection cannot be completely excluded in the given information, but we do not have any evidence.The implant is intact, but all components are loose and have migrated.Based on investigation, the root cause was attributed to a patient related issue.The cause of failure is due to radiolucence and cavities around tibial and talar components.If the device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
It was reported that the patient underwent a total ankle replacement.Allegedly, the patient may need to undergo a revision surgery for subsidence in both tibia and talar component.Patient ankle progressively deforming into valgus.Given the stj fusion, the talar/calc block is everting at the ankle joint.The physician is also planning on stabilizing medial ankle with some sort of deltoid repair/augmentation.

• 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: 17146434
• Report Number: 3010667733-2023-00337
• Device Sequence Number: 20179995
• Product Code: HSN
• UDI-Device Identifier: 00840420124227
• UDI-Public: 00840420124227
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K100886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

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: 1692343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• 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 Sex: Male