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

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Type  Injury  

Event Description

It was reported that during a literature study it was revealed that the patient the hip screw cut out the femoral head and this patient was changed to a hip prothesis.In addition to this the patient had infection which require debridement with antibiotic beads prior to hip prosthesis.

Manufacturer Narrative

It was reported from a literature study that the screw cut out the femoral head and the patient was changed to a hip prothesis.In addition to this the patient had infection which require debridement with antibiotic beads prior to hip prosthesis.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.A clinical analysis noted that one photo with four combined x-ray images labeled figure 7 in the article was provided for review and confirms the reported failure.No individual clinical information has been provided for inclusion in this medical investigation.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.Infection, a potential complication associated with any surgery, can occur and possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.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.

• 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: 9531824
• MDR Text Key: 173082642
• Report Number: 1020279-2019-04659
• 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: 04/23/2020

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: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention