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 03/07/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to infection.Primary surgery was performed on (b)(6) 2019.Patient left hip wound would not heal and was infected.Patient had a washout and debridement prior to first stage revision on (b)(6) 2019, acetabular implants and femoral component were removed.Antibiotic cement spacer implanted.

Manufacturer Narrative

It was reported that a revision surgery was performed due to infection.The complained devices have not been returned for investigation and the reported failure mode could therefore not independently be confirmed.No clinical supporting documents have been provided for the inclusion in the medical assessment.A thorough medical assessment could therefore not be conducted.Three out of five batch numbers in scope have been communicated.No deviations from the standard manufacturing process were revealed for these batch records.Sterilization was conducted according to procedure and within specification.Based on available information the root cause for the reported infection cannot be identified and stays undetermined.The need for corrective action is not indicated.Nevertheless, smith and nephew will continue to monitor the devices for similar issues.The complaint will be reopened should additional information or the complained devices be received.

• 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: 8468048
• MDR Text Key: 140422048
• Report Number: 1020279-2019-01273
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention