MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOLOX; FEMORAL COMPONENT

Catalog Number 76539155

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 01/09/2014

Event Type  Injury  

Manufacturer Narrative

The biolox forte ceramic liner fractured due to a brittle failure mechanism.The liner fractured in a mechanical overload scenario, which can occur if the forces applied to the device exceed the strength of the material.Metal transfer was found on the backside and on the articulating surface of the liner.Metal transfer was also found on the articulating surface of the femoral head.Deformation and scratches along the rim of the acetabular cup were also observed.It is unknown from the information provided if the observed metal transfer and deformation on these components were sustained during removal of the device or were due to impingement of the components in vivo.There was also metal transfer within the female taper region of the femoral head, which is likely where it came into contact with the stem.

Event Description

It was reported that revision surgery was performed.

• Brand Name: BIOLOX
• Type of Device: FEMORAL COMPONENT
• 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: melanie travis ; 1450 brooks road; memphis, TN 38116 ; 9013996233
• MDR Report Key: 3597095
• MDR Text Key: 11750000
• Report Number: 1020279-2014-00050
• Device Sequence Number: 1
• Product Code: LPF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 76539155
• Device Lot Number: 12ET19165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2014
• Initial Date FDA Received: 01/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention