MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE TALAR DOME SZ 4 SULCUS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	220220904
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Cyst(s) (1800); Inadequate Osseointegration (2646)
Date of Event	07/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision surgery of inbone talus due to loosening.The patient was implanted with invision talus and left invision peg talar plate.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.H3 other text : device was discarded.
Additional Manufacturer Narrative
The reported event could be confirmed since images of ct scans were provided and shows loosening of the talar component.Upon further investigation of the ct scans by healthcare professionals the following was observed: ¿the images of the ct scan show the tar at the central part in a sagittal and a frontal plane.The tibial component does not show relevant radiolucence or cysts.The pe cannot be assessed directly, but there is no indirect sign of loosening or dislocation.The talar component shows pretty clear radiolucence specifically around the central peg.There are also some smaller cysts.These findings are compatible with a loosening.Migration or relevant subsidence cannot be confirmed.¿ based on investigation, the root cause was attributed to a patient related issue.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 or Problem Description
It was reported that the patient underwent a revision surgery of inbone talus due to loosening.The patient was implanted with invision talus and left invision peg talar plate.

• Brand Name: INBONE TALAR DOME SZ 4 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: 17465817
• Report Number: 3010667733-2023-00427
• Device Sequence Number: 14130762
• Product Code: HSN
• UDI-Device Identifier: 00840420124234
• UDI-Public: 00840420124234
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K100886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2023

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 Catalogue Number: 220220904
• Device Lot Number: 1691303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2020
• 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: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Race: White