MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL HEAD, SHORT

Catalog Number 310-01-44

Device Problems Loose or Intermittent Connection (1371); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Joint Disorder (2373)

Event Date 01/30/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2012 by dr.(b)(6).Revision of shoulder components due to loosening.

Event Description

It was reported a patient had a revision on the right shoulder.The patient stated that she had right side pain, limited range of motion, stiffness and "other things".No additional information has been provided about the event or the patient.This is one of five products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00618, 1038671-2018-00619, 1038671-2018-00620, 1038671-2018-00621.

Manufacturer Narrative

The complaint products were not received for analysis.The reported product condition of device loosening was not confirmed.The frequency of occurrence ranking scale is very low; therefore, this issue does not appear to be design-related.The company is not aware of receiving any other complaint reports involving parts from the device manufacturing lots.The design history record was requested.As of march 29, 2019, the dhr has not been located.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 are no user-related issues reported.The revision of the shoulder components reported was likely the result of an insufficient bond between the implant and bone, which led to the aseptic (non-infected) loosening.However, this cannot be confirmed because the devices were not available for evaluation and adequate information was not provided.In a review of the labeling, it is known that device specific risks consist of: fracture, migration, loosening, subluxation, or dislocation of the prothesis or any of its components, any of which may require a second surgical intervention or revision.As part of the preoperative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or postoperative period.Revisions or surgical interventions are a known complication found in joint replacements.There were no post explant pictures, x-rays or any patient risk/clinical factors for additional assessment of the event.This device is used for treatment not diagnosis.

• Brand Name: EQUINOXE HUMERAL HEAD, SHORT
• Type of Device: HUMERAL HEAD
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7704546
• MDR Text Key: 114503050
• Report Number: 1038671-2018-00622
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2022
• Device Catalogue Number: 310-01-44
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR