MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE GLENOID, KEELED, CEMENTED, BETA

Catalog Number 314-01-14

Device Problems Migration or Expulsion of Device (1395); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Joint Disorder (2373); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2008.Revision due to wear and migration of the glenoid component, as well as proximal migration of the humerus.

Manufacturer Narrative

The complaint products were not received for analysis.The reported product condition 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 another part from this manufacturing lot of 99 (keeled glenoid), 100 (torque screw kit), 32 (humeral head), 10 (humeral stem) and 100 (replicator plate) pieces that have been in the field since 2007, 2008, 2007, 2008 and 2008, respectively.Therefore, this issue does not appear to be manufacturing related.Aseptic glenoid loosening and prosthesis wear as a long-term complication is predictable in a 62-year-old active male.The average age for a tsa is 70 years old with the assumed activity level and history of degeneration.The prosthesis wear reported was likely the result of being implanted for 8 years and experiencing associated loads consistent with patient body weight during normal activities.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 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.As part of the pre-operative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or the postoperative period.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.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.Pain is a known total joint surgery risk.The clinical risk factors for this patient are that he is described as "active" and he is young, these two conditions are biomechanical stressors on the shoulder implant and could lead to early device failure.The patient had pain for years and suffered with a deteriorating right shoulder condition before the arthroplasty.This device is used for treatment not diagnosis.

Event Description

It was reported that a patient experienced right shoulder revision surgery.It is stated that the patient in now in constant pain.No additional information on the patient or event was provided.This is one of five products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00293, 1038671-2018-00295, 1038671-2018-00296 and 1038671-2018-00297.

• Brand Name: EQUINOXE GLENOID, KEELED, CEMENTED, BETA
• Type of Device: GLENOID
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7423441
• MDR Text Key: 105237384
• Report Number: 1038671-2018-00294
• Device Sequence Number: 1
• Product Code: HSD
• 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: 04/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/05/2012
• Device Catalogue Number: 314-01-14
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR