MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE GLENOID, PEGGED, CEMENTED, ALPHA

Device Problems Loss of Osseointegration (2408); Device Operates Differently Than Expected (2913)

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

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision due to subscapularis insufficiency.

Manufacturer Narrative

In a review of all available information, this subscapularis insufficiency (e.G.Failed subscapularis repair) reported in experience (b)(4) resulted in glenoid loosening.Subscapularis failure after a total shoulder arthroplasty (tsa) is a failure mode associated with the procedure and is not implant related.However, this cannot be confirmed because the component was not returned for evaluation.Per ifu # (b)(4) rev.M states in post op instructions: all patients should be instructed on the limitations of the prosthesis and the possibility of subsequent surgery.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 must be informed that their weight and activity level may affect the longevity of the implant.Patients should be advised to report any pain, decrease in range of motion, swelling, fever, or unusual sounds as this may indicate positional changes in the implant that could lead to premature failure.This device is used for treatment not diagnosis.

Event Description

It was reported that approximately 3-6 months postoperatively from a total shoulder arthroplasty, a female patient was revised to a reverse shoulder without complication due to loosening of the central peg locking mechanism.There was no other information reported.

• Brand Name: EQUINOXE GLENOID, PEGGED, CEMENTED, ALPHA
• Type of Device: GLENOID
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7147885
• MDR Text Key: 95824535
• Report Number: 1038671-2017-00919
• Device Sequence Number: 1
• Product Code: KWT
• 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: 04/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: Yes
• 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