MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE TIB TRAY LEFT SZ 4 LNG; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	220252904
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	04/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation as it remains implanted in the patient.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 x-ray showed delamination of tray and medial mal fracture.The physician did a poly swap and treated the medial mal fracture.
Additional Manufacturer Narrative
The reported event could be confirmed, since evaluation of x-rays provided does show the surface coating of the tibial tray has detached.Medical affairs was asked to review the available information and x-ray provided.According to their review, "the x-rays indeed show a medial malleolar fracture.The slightly displaced medial malleolar fracture fragment ripped of the surface coating from the tibial tray.So in this case the bond between the coating and the bone proved to be stronger than the bond between the tibial tray and its coating.Mechanically, after reduction and fixation of the fracture the medial malleolus and the tibial tray will not be bonded together and will stay a weaker spot.Also, there is a bone cyst medially to the base of the inbone stem.Over time micromotion and metallosis may occur." based on investigation, the root cause was attributed to a patient factors related issue.The event was caused by a fracture in the medial malleolus after a bond had been created with the bone and tibial tray coating.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 x-ray showed delamination of tray and medial mal fracture.The physician did a poly swap and treated the medial mal fracture.

• Brand Name: INBONE TIB TRAY LEFT SZ 4 LNG
• 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: 16996974
• Report Number: 3010667733-2023-00275
• Device Sequence Number: 11626782
• Product Code: HSN
• UDI-Device Identifier: 00840420124326
• UDI-Public: 00840420124326
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K100886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/25/2025
• Device Model Number: 220252904
• Device Catalogue Number: 220252904
• Device Lot Number: 1591125
• 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: 04/27/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2017
• 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 Sex: Male