MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SZ 3-4 LEGION CR XLPE HF INSERT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/23/2020

Event Type  Injury  

Event Description

It was reported that insert swap was performed due to infection.

Manufacturer Narrative

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, risk management review 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.According to clinical/medical investigation, this case reports the patient was taken to the or for i&d of surgical site infections, believed to be the result of a latent infection.As part of the i&d procedure, the poly insert was exchanged.To date, the requested surgical records and x-rays have not been provided to fully evaluate the root cause of the reported infection.Therefore, patient impact beyond the revision cannot be determined.No further medical assessment is warranted at this time.Should clinically relevant documentation or information become available, the clinical/medical task may be re-evaluated.No medical documents were received for investigation.Therefore, no medical assessment can be performed at this time.Infection, a potential complication associated with any surgery, can occur and possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Per the senior author, none of the complications were implant related and were as the article implied, procedure related.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.

• Brand Name: SZ 3-4 LEGION CR XLPE HF INSERT
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10708909
• MDR Text Key: 212249252
• Report Number: 1020279-2020-05596
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• 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: 02/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention