MAUDE Adverse Event Report: EXACTECH, INC. NOVATION ELEMENT FEMORAL STEM, 12/14, COLLARLESS, STANDARD OFFSET, HA COATED

Catalog Number 164-01-09

Device Problems Off-Label Use (1494); Device Slipped (1584); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Disorder (2373); No Code Available (3191)

Event Date 01/22/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2012.Revision due to loosening.This component was implanted off-label with depuy products.

Event Description

It was reported that a patient experienced right hip revision surgery.The revision surgery was of the stem and liner.The stem was grossly loose and easily removed.The patient had classic start up pain.The patient tolerated the procedure well.No additional information about the event or patient has been provided this is one of two products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00268.

Manufacturer Narrative

The femoral stem was received for analysis.The condition of loosening was confirmed.Visual evaluation condition findings (conducted with a 7x or 10x optical) scratches appear consistent with tool marks likely created while removing the stem during the revision surgery.The material removal appears consistent with tool marks likely created while trying to remove biological material to gain access to features of the device that aid in removal of the device.It was reported that a high-speed bur was used to remove overhanging bone laterally.The frequency of occurrence ranking scale is very low; therefore, this does not appear to be design-related.The company is not aware of receiving any complaint reports involving another part from this manufacturing lot of 15 pieces.Complaint data from 2014 through 2018 involving the reported failure for this family of devices was reviewed.Out of 36 complaints involving this product line, 2 other complaints reported loosening of the device and 2 were found to be a manufacturing related issue where the stems were received without ha coating.The device history record was reviewed, and all parts were accepted with conformance to the device specifications.Therefore, this issue does not appear to be manufacturing-related.Properly functioning implants depend on their appropriate fixation in the bone.Although implants may be firmly fixed at the initial surgery, they can become loose over time due to micro-motion.Loosening can be caused by overload or lack of bony on growth.Friction wears away the surfaces of the implant, creating tiny particles that accumulate around the joint.In a process called aseptic (non-infected) loosening, the bond of the implant to the bone is destroyed by the bodies attempt to digest the wear particles.During this process, normal bone is also digested (a condition called osteolysis), which can weaken or even fracture the bone.When the prosthesis becomes loose, or has been loose since the original surgery, the patient may experience pain, change in alignment, or instability.The revision reported was likely the result of aseptic (non-infected) loosening, which damaged the bond between the implant and the bone.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The revision reported was likely the result of aseptic (non-infected) loosening, which is a damaged bond between the implant and the bone.Clinical risks for this patient are that her young age tends to lead to more activity which can affect the implant life and she has noted degenerative joint disease.The hip components were mixed with another manufacturers devices which is not recommended due to the inability to guarantee that implant sizing and geometry will be appropriate.In a review of the labeling - it is a known complication that excessive activity and trauma affecting joint replacements have been associated with premature failure and that fracture, migration, loosening, subluxation, or dislocation of the prosthesis or any of its components, may require a second surgical intervention or revision.Excessive wear of the implant components secondary to impingement of components or damage of articular surfaces.It is a known complication that a patient's age, weight, or activity level would cause the surgeon to expect early failure of the system.Revisions or surgical interventions are a known complication found in joint replacements.All patients should be instructed on the limitations of the prosthesis, the patient should be cautioned to monitor activities and protect the replaced joint from unreasonable stresses and follow the written instructions of the physician with respect to follow-up care and treatment.Never allow ceramic femoral head or liner components to articulate against metal because severe wear of the metal will occur.Use only with these manufacturers acetabular components that feature the same articulating surface diameter.This device is used for treatment not diagnosis.Information about the patient and event have been requested, no new information was provided.

• Brand Name: NOVATION ELEMENT FEMORAL STEM, 12/14, COLLARLESS, STANDARD OFFSET, HA COATED
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7369703
• MDR Text Key: 103432520
• Report Number: 1038671-2018-00267
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K080980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/05/2019

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: Physician
• Device Expiration Date: 11/28/2015
• Device Catalogue Number: 164-01-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2018
• Initial Date FDA Received: 03/26/2018
• Supplement Dates Manufacturer Received: 06/05/2019
• Supplement Dates FDA Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR