MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRAUMA-DUMMY IMPLANT; NAIL, FIXATION, BONE

Catalog Number UNKNOWN

Device Problem Fracture (1260)

Patient Problems Pain (1994); Discomfort (2330)

Event Type  Injury  

Event Description

It was reported that the patient had a femur fracture treated with a rod from hip to knee in (b)(6) 2016.Two of the screws connecting the rod to the patient's knee broke.The leg has still been causing problems for the patient and on (b)(6) 2022, a cat scan was performed.The surgeon suggested a revision surgery.It is unknown whether the revision surgery will be performed.

• Brand Name: TRAUMA-DUMMY IMPLANT
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX
• MDR Report Key: 14207977
• MDR Text Key: 290070364
• Report Number: 1020279-2022-01969
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2023

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: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2022
• Initial Date FDA Received: 04/26/2022
• Supplement Dates Manufacturer Received: 03/30/2023
• Supplement Dates FDA Received: 04/25/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female