MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE CAGE GLENOID MEDIUM, ALPHA

Catalog Number 314-13-03

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 06/20/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant medical devices: 300-10-45, 4270983, anatomic replicator plate 4.5mm; 300-20-02, 4731540, torque defining screw kit; 310-01-44, 4266153, humeral head short 44mm; 313-35-00, 4469399, resurfacing cage k-wire.

Event Description

Primary surgery: (b)(6) 2017.Patients subscapularis muscle tore after a successful total shoulder a few years back.

Manufacturer Narrative

The revision reported was likely the result of a rotator cuff tear.A review of the dhr and the sterilization records was not conducted because the event as described does not appear to be related to the design, manufacturing, or reasonably foreseeable misuse of the device.¿soft tissue damage which may lead to a second surgical intervention or revision¿ is listed in the total joint surgery risks section of the equinoxe shoulder system ifu 700-096-060 rev.M.As stated in the ifu for equinoxe (700-096-060 rev.M), ¿the equinoxe reverse shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.¿.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE CAGE GLENOID MEDIUM, ALPHA
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8757641
• MDR Text Key: 149928547
• Report Number: 1038671-2019-00358
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862172686
• UDI-Public: 10885862172686
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/09/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2021
• Device Catalogue Number: 314-13-03
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/20/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/03/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/09/2019
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR