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

Model Number 314-13-02

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

Patient Problem Failure of Implant (1924)

Event Date 11/23/2021

Event Type  Injury  

Manufacturer Narrative

Pending evaluation, concomitant device(s): 300-51-45, (b)(4) - 4.5 short fa rep plt kit 310-01-44, (b)(4) - equinoxe, humeral head short, 44mm (alpha).

Event Description

Approximately 3.5 yr postop the initial right tsa, this (b)(6) female patient experienced instability and opted to convert anatomic to reverse shoulder.No breakage of device or surgical delay/prolongation.Superior cuff was torn and subscap very thin during revision.Conversion surgery went well, and patient is expected to do well.Patient left or stable.Explants will not be returned per hospital policy.

Manufacturer Narrative

Section h10: (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: CAGE GLENOID SMALL, ALPHA
• 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: 13003531
• MDR Text Key: 286749804
• Report Number: 1038671-2021-00696
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862172679
• UDI-Public: 10885862172679
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113309
• 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: 06/28/2022

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 Expiration Date: 01/15/2023
• Device Model Number: 314-13-02
• Device Catalogue Number: 314-13-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 06/06/2022
• Supplement Dates FDA Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2018
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female