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

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

In a scientific publication, gavaskar, "helical blade or the integrated lag screws: a matched pair analysis of 100 patients with unstable trochanteric fractures" it was reported that the patient underwent a hemi arthroplasty.

Manufacturer Narrative

Results of investigation: the devices, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A clinical analysis indicated that these complaints are from a literature review.The study revealed patients who underwent primary implantation of either genesis ii or legion primary were revised for multiple reasons including infection, instability, stiffness , extensor mechanism injury, aseptic loosening, patellar maltracking, locking mechanism dissociation, hematoma, recurrent hemarthrosis, pain, fracture, patellar clunk, unknown reasons.The master complaint number is (b)(6) are under sub master c-283459 from south korea.These presented with, aseptic loosening, polyethylene wear, instability and infection.No specific individual clinical/medical documentation was provided for this investigation.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as but not limited to traumatic injury, surgical technique, implant failure or design of device.Without the return of the actual product involved and no patient medical records, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: TRAUMA IMPLANT
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9536196
• MDR Text Key: 173748810
• Report Number: 1020279-2019-04772
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/31/2019
• Supplement Dates Manufacturer Received: 09/22/2020
• Supplement Dates FDA Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention