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

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 04/29/2019

Event Type  Injury  

Event Description

It was reported that revision surgery was performed for the extraction of the implants due to infection.

Manufacturer Narrative

It was reported that revision surgery was performed for the extraction of the implants due to infection.The associated devices were not returned for evaluation.Therefore a product analysis could not be performed.After repeated requests, smith and nephew has been unable to obtain device details, except for the genesis ii ps high flexion insert.A review of the manufacturing records for this part did not reveal any deviation from the standard manufacturing processes and the review of the complaint history revealed no prior complaints for the listed failure mode with the same batch number.The lot number for other devices was not provided.Therefore, device history record, complaint history and sterilization documentation review cannot be conducted for these devices.Our investigation including a sterilization review of the insert noted the device was sterilized according to sterilization release documentation from quality control.There is no information that would suggest the implanted device failed to meet specifications.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.No relevant documentation was provided to perform a thorough medical investigation, thus the root cause of the infection remains unknown.Without the return of the actual products involved and no product information for other devices besides the insert, our investigation of this report is inconclusive.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 devices or additional information be received, the complaint will be reopened.

• 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: 8628628
• MDR Text Key: 145663936
• Report Number: 1020279-2019-02013
• 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: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention