MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOLOX FORTE CER 32 HD 12/14 +0; FEMORAL HEAD

Catalog Number 71330320

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problem Fall (1848)

Event Date 11/24/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a revision hip surgery was performed due to ceramic femoral head failure after the patient fell.

Manufacturer Narrative

The associated complaint device was returned and evaluated.The manufacturing records were not reviewed for this device, the lot number is unknown.A visual inspection of the returned device confirms the ceramic head has fractured into many pieces.An evaluation performed by our research lab noted the taper bore surfaces showed metal transfer and indicated the potential fracture initiation site was near the gage point.This region is known to be the highest stress area based on finite element analysis.The ceramic femoral head potentially failed due to an overload fracture.This can occur when the applied forces exceed the yield strength of the material.This could be caused by an impact load to the femoral head, which can result in higher forces than are typically experienced during normal gait patterns.Our investigation did not determine a specific cause of the stated failure.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This investigation could not verify or identify any evidence of product contribution to the reported problem.Based on this investigation, the need for corrective action is not indicated.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: BIOLOX FORTE CER 32 HD 12/14 +0
• Type of Device: FEMORAL HEAD
• 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: robert rust ; 1450 brooks road; memphis, TN 38116 ; 9013991624
• MDR Report Key: 5264427
• MDR Text Key: 32616503
• Report Number: 1020279-2015-00834
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71330320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2015
• 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: 59 YR
• Patient Weight: 94