MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; 36MM GLENOSPHERE

Model Number 320-01-36

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

Patient Problem Failure of Implant (1924)

Event Date 11/10/2021

Event Type  Injury  

Event Description

As reported approximately 3 yrs postop the initial implant, this (b)(6) female patient¿s left shoulder was revised due to instability.The patient was last known to be in stable condition following the event.Devices not returning due to facility policy.

Manufacturer Narrative

Pending evaluation: concomitant device(s): (b)(4) - rs glenoid plate post aug, 8 deg, right.(b)(4) - eq rev locking screw.(b)(4) - equinoxe, humeral stem primary, press fit 11mm.(b)(4) - eq reverse torque defining screw kit.(b)(4) - equinoxe reverse tray adapter plate tray +0.(b)(4) - 36mm humeral liner +0 unconstrained.No information provided in the following: (b)(4).

Manufacturer Narrative

(h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the instability and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• Brand Name: EQUINOXE
• Type of Device: 36MM GLENOSPHERE
• 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: 12913412
• MDR Text Key: 286449175
• Report Number: 1038671-2021-00651
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086372
• UDI-Public: 10885862086372
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K093275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2022

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 Model Number: 320-01-36
• Device Catalogue Number: 320-01-36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 04/28/2022
• Supplement Dates FDA Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2019
• 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): Required Intervention; Hospitalization
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 68 KG