MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; 7X80MM DISTAL STEM MODULAR CEMENTED

Model Number	308-01-07
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 320-36-10 - 36mm humeral liner +0mm constrained, 320-10-00 - equinoxe reverse tray adapter plate tray +0, 320-35-02 - small superior augment glenoid plate, 308-05-19 - distal fixation ring ha 19.5, 308-09-00 - small prox body +0, 320-32-36 - expanded glenosphere, 36mm, for small reverse.No information provided.
Event or Problem Description
As reported, approximately 5 months post-op the initial tsa, this (b)(6) female patient presented aseptic humeral loosening with pain and swelling in the arm.No traumatic event was reported.The case report form indicates this event is possibly related to devices and/or procedure.This event report was received through clinical data collection activities.No action was taken, patient is wearing a brace.Outcome is reported as "ongoing".
Additional Manufacturer Narrative
(h3) the humeral loosening reported may have been the result of both patient-related conditions and an insufficient bond between the implants and the bone.However, this cannot be confirmed as the patient has not been revised; therefore, the devices are not available for evaluation and x-rays were not provided.Section h11: the following sections have corrected information: (d4) serial number: (b)(6), expiration date: 21-jun-2026.(h4) device manufacture date: 29-oct-2019.(h6) component code: 4755, part/component/sub-assembly term not applicable.

• Brand Name: EQUINOXE
• Common Device Name: 7X80MM DISTAL STEM MODULAR CEMENTED
• 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: 13415195
• Report Number: 1038671-2022-00102
• Device Sequence Number: 3963177
• Product Code: KWT
• UDI-Device Identifier: 10885862267887
• UDI-Public: 10885862267887
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K143659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/21/2026
• Device Model Number: 308-01-07
• Device Catalogue Number: 308-01-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American