MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 33650013

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

Patient Problems Wound Dehiscence (1154); Loss of Range of Motion (2032)

Event Date 07/07/2021

Event Type  Injury  

Manufacturer Narrative

Device will not be returned as it remains implanted.If additional information becomes available, it will be provided on a supplemental report.

Event Description

It was reported that the patient had an achilles lengthening which had wound breakdown.The patient underwent irrigation and debridement and split thickness skin grafting.This has gone on to heal.The patient was indicated for a split thickness skin graft.Risks, benefits complications and alternatives of this were discussed in detail.The surgeon performed irrigation and debridement of the right achilles with application of skin graft to treat the patient¿s complaints of stiffness and limited ankle dorsiflexion.This is the fourth surgery for this patient.

• Brand Name: INFINITY TOTAL ANKLE SYSTEM
• 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: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 12317066
• MDR Text Key: 266368980
• Report Number: 0001043534-2021-00144
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00840420122544
• UDI-Public: 00840420122544
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/12/2021

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 Model Number: 33650013
• Device Catalogue Number: 33650013
• Device Lot Number: 1619034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/17/2021
• Initial Date FDA Received: 08/12/2021
• 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: 70 YR
• Patient Weight: 104