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

Model Number 314-13-13

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

The revision reported was likely the result of prosthesis wear which may have be related to third body wear and/or patient factors.However, this cannot be confirmed as the devices were not returned for evaluation and no other information regarding the revision was provided.Concomitant medical products: 310-03-47, 1706635 - equinoxe, humeral head expanded, 47mm (beta).

Event Description

Approximately 5 years postop the initial install of right tsa, this (b)(6) male patient¿s right poly was worn.Surgeon decided to implant a new glenoid component.Patient was last known to be in stable condition following the event.Device will not return due to facility policy.

• Brand Name: EQUINOXE
• Type of Device: CAGE GLENOID MEDIUM, BETA
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesvile FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 10935373
• MDR Text Key: 219184630
• Report Number: 1038671-2020-00632
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862172693
• UDI-Public: 10885862172693
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2020
• Device Model Number: 314-13-13
• Device Catalogue Number: 314-13-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/24/2015
• 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: 56 YR