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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Limited Mobility Of The Implanted Joint (2671)

Event Date 07/03/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Contaminant devices: humeral head, replicator plate.Square drive torque screw.

Event Description

Revision due to weakened rotator cuff.Patient is having lack of motion.

Manufacturer Narrative

Section h10: (e3) occupation: physician (h3) the revision was being performed to convert from an exactech anatomic shoulder to an exactech reverse due to a weakened rotator cuff.The patient was having pain and lack of motion due to the insufficient rotator cuff.There is no indication that there was a malfunction with the device, the most likely cause of the rotator cuff injury is related to the patient condition.Equinoxe is intended for individuals who have degenerative disease of the shoulder.Product was not returned.No additional information provided.Indications for use: the equinoxe shoulder system is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.Rotator cuff strains or tears are caused by overuse or acute injury.The tendons that connect muscles to bones can overstretch (strain) or tear, partially or completely.The rotator cuff can also strain or tear after a fall, a car accident, or another sudden injury.These injuries typically cause intense and immediate pain.[1] [1] https://www.Healthline.Com/health/rotator-cuff-injury#risk-factors (oct 2016) equinoxe humeral stem, primary, press-fit; equinoxe anatomic replicator plate; equinoxe torque defining screw; equinoxe humeral had, short; equinoxe cage glenoid, small no information provided in the following section(s): a2, a3, a5, b6, b7, d4, d6, e3, g5, g8, h4, h6, h7.

• Brand Name: EQUINOXE
• Type of Device: GLENOID
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8821657
• MDR Text Key: 152042760
• Report Number: 1038671-2019-00372
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2019
• Initial Date FDA Received: 07/24/2019
• Supplement Dates Manufacturer Received: 10/02/2019
• Supplement Dates FDA Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention