MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; SHOULDER COMPONENTS

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

Patient Problem Joint Dislocation (2374)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

Pending evaluation.

Event Description

It was reported that the primary surgery occurred on (b)(6) 2013.Chronic dislocation.No action taken.The surgeon is not revising because the patient is (b)(6) years old.

Manufacturer Narrative

Section h10: (b2) outcomes attributed to adverse event: added check for hospitalization - initial or prolonged (h3) as reported, the initial implant was on (b)(6) 2013.The patient has chronic dislocation.No action taken.The surgeon is not revising because the patient is 92 years old.The case report form indicates this event is unlikely related to devices and definitely related to procedure.This event report was received through clinical data collection activities.In a review of the labeling and ifu 700-096-004 rev.N, 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.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design, manufacturing, or patient related issues.The cause of the revision is most likely is related to the patient¿s underlying condition; however, that could not be confirmed.(h6) evaluation codes: 2374, 2993.Section h11: *the following sections have corrected data: (b5) as reported, the initial implant was on (b)(6) 2013.The patient has chronic dislocation.No action taken.The surgeon is not revising because the patient is 92 years old.The case report form indicates this event is unlikely related to devices and definitely related to procedure.This event report was received through clinical data collection activities.(h1) type of reportable event: serious injury *no information provided in the following section(s): b6, b7, d4, d7, d11, g5, g8, h4, h7.

Event Description

As reported, the initial implant was on (b)(6) 2013.The patient has chronic dislocation.No action taken.The surgeon is not revising because the patient is 92 years old.The case report form indicates this event is unlikely related to devices and definitely related to procedure.This event report was received through clinical data collection activities.

Manufacturer Narrative

(d10) concomitant device(s): 300-01-17 - equinoxe humeral stem primary press fit 17mm: 2580862.320-01-46 - equinoxe reverse 46mm glenosphere: 2646046.320-10-00 - equinoxe reverse tray adapter plate tray +0: 2665265.320-15-05 - eq rev locking screw: 2669840.320-20-00 - eq reverse torque defining screw kit: 2672229.320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm: 2586575.320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm: 2613272.320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm: 2494641.320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm: 2528005.320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm: 2115184.320-46-00 - equinoxe reverse 46mm humeral liner +0: 2427311.321-20-00 - equinoxe reverse shoulder drill kit: 2655480.

• Brand Name: EQUINOXE
• Type of Device: SHOULDER COMPONENTS
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 9208024
• MDR Text Key: 189075919
• Report Number: 1038671-2019-00527
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 92 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White