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

Model Number 33650002

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  Injury  

Manufacturer Narrative

The part and lot of the suspect device was not identified, therefore, the manufacturer cannot determine the suspect device.However, the suspect devices in use are part # 200347901, lot # 1611689; part # 220220901, lot # 1579249; part # 33650002, lot # 1590838; and part # 33651108, lot # 1584487.Manufacture date for lot 1611689 is 9/26/2017; manufacture date for lot 1579249 is 11/07/2016; manufacture date for lot 1590838 is 05/02/2016; manufacture date for lot 1584487 is 12/05/2016.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

Allegedly, the patient requires a revision surgery.No additional information is available at this time.

Event Description

Allegedly, it was reported that tibial component subsided requiring a revision surgery.

• 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; arlington TN 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: 1023 cherry road; memphis, TN 38117 ; 9014516318
• MDR Report Key: 7698718
• MDR Text Key: 114327885
• Report Number: 1043534-2018-00068
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

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
• Device Operator: Other
• Device Model Number: 33650002
• Device Lot Number: 1590838
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/22/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/22/2018
• Initial Date FDA Received: 07/18/2018
• Supplement Dates Manufacturer Received: 06/22/2018
• Supplement Dates FDA Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TALAR STEM, TALAR DOME, TIBIAL TRAY, POLY
• Patient Outcome(s): Required Intervention