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

Catalog Number	320-02-42
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Date of Event	04/26/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8633198
• Report Number: 1038671-2019-00284
• Device Sequence Number: 11173734
• Product Code: KWT
• UDI-Device Identifier: 10885862186768
• UDI-Public: 10885862186768
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/22/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 320-02-42
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/26/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 05/22/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 74