MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-13-02
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Lack of Effect (4065)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	05/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A5.Information not provided d10.Concomitants: 312-01-41 - resurfacing humeral head 41mm 312-01-01 - resurfacing cage, 25mm.
Event or Problem Description
It was reported via clinical study that the 62 yo female patient experienced aseptic glenoid loosening with loss of motion and sudden shoulder pain.The date of event onset is (b)(6) 2023.The patient was revised on (b)(6) /2023.The patient¿s outcome was last known as resolved.
Event or Problem Description
It was reported via clinical study that the 62 yo female patient experienced aseptic glenoid loosening with loss of motion and sudden shoulder pain.The date of event onset is (b)(6) 2023.The patient was revised on (b)(6) 2023.The patient¿s outcome was last known as resolved.The case report form indicates this event is definitely not related to devices and unlikely related to procedure.
Additional Manufacturer Narrative
The revision reported was likely the result of an insufficient bond between the glenoid component and the bone, which led to aseptic (non-infected) glenoid loosening.The extent and root cause of the glenoid loosening could not be determined as the device was not returned, and serial information, images, and radiographs were not provided.Section h11: *the following sections have corrected information: (a2) age at the time of event: 62 years (b5) describe event or problem: it was reported via clinical study that the 62 yo female patient experienced aseptic glenoid loosening with loss of motion and sudden shoulder pain.The date of event onset is (b)(6) 2023.The patient was revised on (b)(6) 2023.The patient¿s outcome was last known as resolved.The case report form indicates this event is definitely not related to devices and unlikely related to procedure.(h6) component code: 734, bearings.

• Brand Name: EQUINOXE
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 17268401
• Report Number: 1038671-2023-01567
• Device Sequence Number: 20323494
• Product Code: KWS
• UDI-Device Identifier: 10885862172679
• UDI-Public: 10885862172679
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2024

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 Catalogue Number: 314-13-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 01/25/2024; 08/21/2024
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 01/25/2024; 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 50 KG