MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOLOX FORTE CER 32 HD 12/14 +0; REFLECTION CERAMIC HIPS SYS.

Catalog Number 71330320

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 01/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported a revision was performed and delayed over 30 minutes due to implant failure after patient fall.

Manufacturer Narrative

The associated complaint device was returned and evaluated.A visual inspection of the returned device confirms the ceramic head has shattered into many pieces.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history revealed prior complaints for the listed failure mode, no prior complaints for the listed lot.An evaluation performed by our research lab noted the ceramic femoral head was fractured into several pieces of varying sizes.Visual analysis showed metal transfer on the taper bore and indicated the most likely site of fracture initiation was the gage point, which 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 expected usage.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: REFLECTION CERAMIC HIPS SYS.
• 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: 5398566
• MDR Text Key: 37094842
• Report Number: 1020279-2016-00086
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71330320
• Device Lot Number: 15KM00967
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• 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: 109