MAUDE Adverse Event Report: EXACTECH, INC. NOVATION CERAMIC AHS CLUSTER-HOLE SHELL, PLASMA COATED

Catalog Number 140-01-54

Device Problem Fracture (1260)

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

Event Date 07/07/2017

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2013.Revision of hip components due to ceramic liner fracture.

Event Description

Information was requested, and no additional information was provided.This is one of six products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00461, 1038671-2017-00462, 1038671-2017-00463, 1038671-2017-00464, 1038671-2017-00465.

Manufacturer Narrative

The complaint products were received for analysis.The broken ceramic liner was confirmed.Visual evaluation condition/findings (conducted with a 7x or 10x optical).The liner was returned in multiple fragments with missing fragments, there is a probability that the analysis of the fragments and the fracture surface remains incomplete.Femoral head has metal transfer that appears consistent with secondary metal transfer that occurred after the fracture of the liner.The frequency of occurrence ranking scale is low; therefore, this does not appear to be design related.Exactech is not aware of receiving any complaint reports involving another part from this manufacturing lot of 21 pieces made in 2013.Exactech complaint data from 2014 through 2018 involving the reported failure for this family of devices was reviewed.The investigations for those incidences have not identified any evidence that a manufacturing issue caused or contributed to this reported issue.Therefore, this does not appear to be manufacturing-related.There were no user-related issues reported.The revision reported was potentially the result of an insufficient or misaligned fixation of the insert in the metal cup leading to a misaligned position of the insert, causing a local stress rising and fracture of the insert.However, this cannot be confirmed because the part was severely fragmented and not all fragments of the liner were received for evaluation.In a review of the labeling, 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.Patients should be advised to report any pain, decrease in range of motion, swelling, fever, or unusual sounds (e.G.Clicking or squeaking) as this may indicate positional changes in the implant that could lead to premature failure.Device specific risks - fracture, migration, loosening, subluxation, or dislocation of the prosthesis or any of its components, any of which may require a second surgical intervention or revision this device is used for treatment not diagnosis.

• Brand Name: NOVATION CERAMIC AHS CLUSTER-HOLE SHELL, PLASMA COATED
• Type of Device: CLUSTER-HOLE SHELL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville 32653
• MDR Report Key: 6717038
• MDR Text Key: 80159660
• Report Number: 1038671-2017-00466
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: P050039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/15/2019

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: 09/22/2018
• Device Catalogue Number: 140-01-54
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2017
• Initial Date FDA Received: 07/17/2017
• Supplement Dates Manufacturer Received: 04/15/2019
• Supplement Dates FDA Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention