MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Device Problem Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Type  Injury  

Event Description

In a scientific publication, author: ying yong et all.,"internal fixation failure in elderly patients after artificial joint replacement in the treatment of femoral intertrochanteric fractures" it was reported that the greater trochanteric fracture of the patient was displaced due to wire cable cutting, without dislocation of the joint.The patient was unwilling to undergo a re-operation.The publication states that 3 cases were conducted with conventional femoral stem on the femoral side and 18 cases with echelon femoral straight stem.There is not enough information to make a cross-check between the patients and the devices.

Manufacturer Narrative

It was reported from a literature review of the paper: 'internal fixation failure in elderly patients after artificial joint replacement in the treatment of femoral intertrochanteric fractures' by ying yong et al, that the patient had a greater trochanteric fracture displaced due to wire cable cutting, without dislocation of the joint.The patient was unwilling to undergo a re-operation.The affected complaint 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.Based on this investigation, the need for corrective action is not indicated.The cause of the reported event was reported as wire cable cutting.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we 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: HIP IMPLANT
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9770961
• MDR Text Key: 181422539
• Report Number: 1020279-2020-00728
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention