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

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported that an intertan failed.Screw was not seated right.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.A clinical analysis concluded it was reported that an intertan screw had failed and that the screw was not seated right.Based on the provided x-rays reviewed by our medical director, there appears to be a possible new femoral neck fracture as well as a non-union of the femur fracture.Both could have led to instability and a fatigue failure of the nail.In addition, no documentation was provided in relation to the patient's rehab history, weight bearing compliance or the possibility of any trauma that was incurred.Without the supporting patient medical history, imaging, and/or the analysis of the explanted components, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The reported event cannot be assessed and a thorough medical assessment cannot be performed¿.When notification has been made that all medical documentation has provided this complaint will be re-evaluated and a thorough medical assessment rendered.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.

• Brand Name: UNKNOWN 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: 9586075
• MDR Text Key: 174865444
• Report Number: 1020279-2020-00246
• 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: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other