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

Device Problem Insufficient Information (3190)

Patient Problems Necrosis (1971); Injury (2348)

Event Type  Injury  

Event Description

In a scientific publication, zhang zeng 2017, "a retrospective analysis of the intertan nail and proximal femoral nail anti-rotation in the treatment of intertrochanteric fractures in elderly patients with osteoporosis: a minimum follow-up of 3 years" it was revealed that the patient presented avascular necrosis of the femoral head a medical intervention was required.

Manufacturer Narrative

It was reported from a literature study that the patient presented avascular necrosis of the femoral head, and a medical intervention was required.The affected device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.Possible causes could include but are not limited to traumatic injury or patient medical history.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or 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: 9532790
• MDR Text Key: 173733798
• Report Number: 1020279-2019-04691
• 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: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention