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

Model Number 200010901

Device Problem Disassembly (1168)

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

Event Date 06/27/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.Films were supplied for review.Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.

Event Description

It was reported that the patient underwent a total ankle replacement surgery.Allegedly, the tibia component appeared to have loosened on films 22 months post-op.The patient underwent a revision surgery 26 months post-op to remove and replace the loosened tibia component.The explanted tibia components appeared to have bone on-growth over small areas only.The surgeon mentioned that the kinematics of the patient's ankle with the implant were awkward in that the joint opened anteriorly in plantarflexion rather than smooth concentric articulation, possibly due to the low joint line, and that this kinematic issue could be one contributor to loosening.

Manufacturer Narrative

Radiographic images were provided from (b)(6) 2015 and (b)(6) 2017.Comparing the two images it does appear that there are areas with less bone/implant interface around the tibial components.

• 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: matthew parrish ; 1023 cherry road; 901451-631
• MDR Report Key: 6735871
• MDR Text Key: 80793587
• Report Number: 1043534-2017-00080
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K051023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 200010901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/27/2017
• Event Location: Home
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 62 YR