MAUDE Adverse Event Report: SMITH & NEPHEW, INC.; HIP PROSTHESIS

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Unspecified Infection (1930)

Event Date 05/09/2016

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported a revision surgery was performed due to suspected infection and dislocation of implant.

Manufacturer Narrative

The associated complaint device was not returned.The clinical/medical team concluded this case reports the patient had an open reduction was scheduled to undergo a 3rd hip revision approximately 2 weeks post reduction for suspected infection and dislocation of a constrained r3 acetabular liner.It is further reported that the patient had ¿evacuation of hematoma from his hip wound owing to his previous surgical open reduction¿ and that ¿the constrained liner was not locking over the femoral head¿ ((b)(4)).However, it is reported that there were no implants removed at the surgery on the (b)(6) 2016 as there were no constrained liner available to replace the one that was currently engaged in the r3 shell.Per report, the surgeon decided on the day of surgery to retain the existing liner and bring the patient back on a different day when a new liner would be available for use.No lab results, op notes, x-rays, or other clinically relevant information have been provided for inclusion in the medical assessment.Additionally, it is reported that the constrained liner was destroyed in an additional surgery and will not be returned for evaluation.Based on the information provided, unable to rule out infection, trauma, and procedural/device variances as contributing to the event.No further clinical assessment is warranted at this time.Without the actual product involved and/or device information, a manufacturing review cannot be performed and our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: yagna angirish ; 1450 brooks rd; memphis, TN 38116 ; 9013995009
• MDR Report Key: 5685752
• MDR Text Key: 46114165
• Report Number: 1020279-2016-00431
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 92 YR