MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRIGEN HINDFOOT FUSION NAIL IMPL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Malunion of Bone (4529)

Event Date 01/16/2015

Event Type  Injury  

Manufacturer Narrative

Reference number: (b)(4).

Event Description

It was reported that, after a primary trauma surgery had been performed on the patient's left hindfoot on (b)(6) 2012, in which a hfn 11. 5mm x 16cm left nail was implanted along with four screws placed across the proximal tibial (x2), distal transverse (x1) and distal posteroanterior (x1) region to treat avascular necrosis of the talus, the patient experienced nonunion of ankle and subtalar joints, cortical hypertrophy and a loosening of the posteroanterior distal screw. A revision surgery was performed on (b)(6) 2015 to treat this adverse event. It is unknown which devices were explanted during this procedure, and an unspecified fusion plate was implanted instead. The transverse screw was previously removed on a procedure performed on (b)(6) 2014. This incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered; therefore, additional information is not known and it is not possible to collect it.

• Brand Name: UNKN TRIGEN HINDFOOT FUSION NAIL IMPL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12788043
• MDR Text Key: 280591655
• Report Number: 1020279-2021-07993
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• 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 Treatment Data

Date Received: 11/10/2021 Patient Sequence Number: 1