MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INBONE (R); PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 200347901

Device Problem Disassembly (1168)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2017

Event Type  malfunction  

Manufacturer Narrative

Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

Event Description

It was reported that the patient underwent an ankle replacement surgery.Allegedly, the talar stem and talar dome were combined on the back table.After the device was implanted and final x-rays were taken, it appeared that the talar stem released from the talar dome.It was decided to leave the implant as is.No patient complications have been reported.

• Brand Name: INBONE (R)
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; 38002
• Manufacturer Contact: timothy nickel ; 1023 cherry road; 901451-631
• MDR Report Key: 6533445
• MDR Text Key: 74044722
• Report Number: 1043534-2017-00043
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 200347901
• Device Lot Number: 1584342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/04/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/04/2017
• Initial Date FDA Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2016
• 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