MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET

Catalog Number 320-02-42

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 04/26/2019

Event Type  Injury  

Manufacturer Narrative

The revision reported was likely the result of calcification of the deltoid, which led to repeated dislocation of the shoulder.This is a clinical event that does not appear to be related to the design, manufacturing, or reasonably foreseeable misuse of the devices.Therefore, dhrs and sterilization records will not be reviewed.In a review of the labeling and ifu 700-096-060 rev.M - contraindication - inadequate or malformed bone that precludes adequate support or fixation of the prosthesis.Also, 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.Surgical interventions/revisions are well known risks for joint arthroplasty.Concomitant medical devices: 320-10-05, 5698051 - humeral tray, +5; 320-42-00, 5899120 - humeral liner, 42mm, +0; 320-20-00, not reported - torque screw; 320-15-05, 5828006 - glenosphere locking screw; 320-15-06, 5259280 - sup/post aug baseplate; 320-15-34, 5771383 - 34mm screw; 320-15-34, 5840229 - 34mm screw; 320-20-18, 5860034 - 18mm screw; 320-20-26, 5766482 - 26mm screw; 320-11-00, not reported - 11mm screw.

Event Description

Revision performed on (b)(6) 2019.This shoulder was dislocating due to calcification of the deltoid which kept pushing the humerus anterior and dislocating the shoulder.

• Brand Name: EQUINOXE
• Type of Device: RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 8633198
• MDR Text Key: 145836787
• Report Number: 1038671-2019-00284
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862186768
• UDI-Public: 10885862186768
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 320-02-42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/26/2019
• Date Manufacturer Received: 04/26/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 74