MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE TIB TRAY RT SZ 3 LNG; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 220222903

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/12/2024

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported it was reported that two implants were found to be defective during a primary prophecy inbone case.The tibia fractured as a result of the repeated impact to the tibial plate and stem.Arthrex plates and screws were used to manage the fracture as well as bone cement to help fixate the inbone stem.New implants were used to complete the case successfully.

• Brand Name: INBONE TIB TRAY RT SZ 3 LNG
• Type of Device: 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: 19071615
• MDR Text Key: 339720289
• Report Number: 3010667733-2024-00192
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00840420124272
• UDI-Public: 00840420124272
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K100886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/09/2024

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 220222903
• Device Lot Number: 1723084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention