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

Model Number 314-13-13

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 07/01/2021

Event Type  Injury  

Manufacturer Narrative

Device evaluated by manufacturer? pending evaluation.Concomitant medical device(s): 300-62-02, stemless humeral comp integrip, cage, size 2.310-62-47.Stemless humeral head 47mm x 15mm x beta.

Event Description

As reported, this (b)(6) y/o male patient¿s pain and function have been progressively worsening without injury to the right shoulder.The patient was scheduled for a revision due to glenoid loosening.Patient was last known to be in stable condition following the event.The patient¿s outcome is reported as continuing.All information received from a clinical study database.

Manufacturer Narrative

Section h10: (d4) serial number: (b)(6), expiration date: 04-sep-2023 (d6b) if explanted, give date: (b)(6) 2022 (h3) the revision reported was likely the result of both patient-related conditions and an insufficient bond between the glenoid component and the bone, which led to aseptic (non-infected) glenoid loosening.However, this cannot be confirmed as the explants and x-rays were not available for evaluation.(h4) device manufacture date: 06-sep-2018 *no information provided in the following section(s): b6, b7, c, d8, g7, h7, h9 section h11: *the following sections have corrected information: d11) concomitant device(s): 300-62-02, 6177405 - stemless humeral comp integrip, cage, size 2 310-62-47,6160794 - stemless humeral head 47mm x 15mm x beta.

• 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; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 12868229
• MDR Text Key: 281197175
• Report Number: 1038671-2021-00637
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2022

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 Expiration Date: 09/04/2023
• 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
• Initial Date Manufacturer Received: 11/04/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 03/28/2022
• Supplement Dates FDA Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White