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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. UNKN TRIGEN HINDFOOT FUSION NAIL IMPL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
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.
 
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Brand NameUNKN TRIGEN HINDFOOT FUSION NAIL IMPL
Type of DeviceROD, 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 Key12788043
MDR Text Key280591655
Report Number1020279-2021-07993
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received11/10/2021
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 Received01/18/2022
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
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