MAUDE Adverse Event Report: EXACTECH, INC. FEMORAL HEAD

Device Problems Deformation Due to Compressive Stress (2889); Naturally Worn (2988)

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

Event Date 07/02/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: revision due to poly wear.

Manufacturer Narrative

Device evaluated by mfr: the complaint products were no received for analysis.The reported malfunction/product conditions were not confirmed as the devices were not returned.The frequency of occurrence ranking scale is very low; therefore, this issue does not appear to be design-related.The manufacturing data could not be reviewed because no serial/lot numbers were provided.There does not appear to be any user-related issues that have contributed to the reported event.The revision reported was likely the result of prosthesis wear due to nearly 20 years of implantation.However, this cannot be confirmed as the devices were not available for evaluation it is found in review of the labeling that a known device specific included surgical interventions and revisions.Physicians should consider femoral and acetabular component placement and malposition, femoral head component diameter and the effect of femoral head component "sleeves and skirts" on range of motion.A malpositioned component may increase the probability for impingement, disassociation, dislocation, wear and revision surgery.It is a known risk that there may be subsequent revisions or surgical interventions of joint replacement devices.Only qualified surgeons are to use these products: who are fully knowledgeable about all aspects of the surgical technique and use of these implants, have full knowledge about the system compatibility's, and must be fully trained to properly use the system and instrumentation.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 most likely result of prosthesis wear is due to nearly 20 years of implantation.This device is used for treatment, not diagnosis.Corrected data: implanted date, explanted date.

Event Description

This is one of two products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00569.

• Brand Name: FEMORAL HEAD
• Type of Device: FEMORAL HEAD
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7685566
• MDR Text Key: 113899846
• Report Number: 1038671-2018-00587
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/08/2019

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/13/2018
• Supplement Dates Manufacturer Received: 03/06/2019
• Supplement Dates FDA Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention