MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INVISION¿ TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	60012002
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Metal Related Pathology (4530)
Date of Event	06/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for evaluation as it remains in the patient.When additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the talar components are loose.Has caused significant metallosis in surrounding tissues.At least one of the screws through the plate broke too.Will have to undergo another surgery.
Additional Manufacturer Narrative
Correction h6 results code, conclusion code.The reported event could be confirmed since images of ct scans were provided and matches the alleged failure mode.There are many clinical factors that can affect the results of any surgery, such as surgical technique, pre-operative and post-operative care, the implant, patient pathology and daily activity.A medical professional reviewed the received information and noted the following: ¿the breakage of a screw was reliably assessed on the mpr of the ct-scan.Poor bone quality and incomplete subtalar fusion led to loosening and subsidence of the talar component and unavoidable breakage of a screw.Multiple interventions reflecting the initial complex hindfoot pathology relate to the bone quality.¿ based on investigation, the root cause was attributed to a patient factor related issue.As noted by a medical professional, the failure was caused by poor bone quality and incomplete subtalar fusion.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 talar components are loose.Has caused significant metallosis in surrounding tissues.At least one of the screws through the plate broke too.Will have to undergo another surgery.

• Brand Name: INVISION¿ TOTAL ANKLE SYSTEM
• 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: 15048322
• Report Number: 3010667733-2022-00250
• Device Sequence Number: 5515735
• Product Code: HSN
• UDI-Device Identifier: 00840420193766
• UDI-Public: 00840420193766
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K171067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 60012002
• Device Catalogue Number: 60012002
• Device Lot Number: 1620010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2019
• 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: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female