MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID L, POST AUG, LEFT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE CAGE GLENOID L, POST AUG, LEFT
Medical Device Problem Codes	Mechanical Problem (1384); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Implant Pain (4561); Medical device site infection (4845)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a clinical equinoxe shoulder study, that a 66 yo male patient, who had an initial left shoulder implanted on (b)(6) 2018, developed worsening shoulder pain w/out inciting an event on an unknown date in 2022.X-rays demonstrate glenoid loosening and osteolysis around stemless component.The patient had a subacromial corticosteroid injection.Relative rest, activity modification, and nsaids were prescribed.Outcome is continuing.The patient is considering revision surgery.The study indicates that this is definitely not related to the devices or the procedure.No further information known.
Additional Manufacturer Narrative
D10: concomitants serial number item number and full description (b)(6), 300-62-03, stemless humeral comp integrip, cage, size 3.(b)(6), 310-60-53, stemless humeral head extra short, 53mm (beta).
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b5, d6b, h6.Mdr section codes updated/corrected: a, b, c, d, e, f, g.The revision reported may be the result of the glenoid loosening and loss of range of motion as reported.However, the series of events and contributing factors to each cannot be confirmed and any potential contributions from user or patient-related contributing factors to the event cannot be evaluated as no radiograph, images, or clinical information was provided.According to the reported details, there was likely no infection present at the time of revision.The reason for the loosening cannot be conclusively determined; however, it may be related to an underlying patient condition.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported via a clinical equinoxe shoulder study, that a patient, who had an initial left shoulder implanted, developed worsening shoulder pain w/out inciting an event on an unknown date in 2022.X-rays demonstrate glenoid loosening and osteolysis around the stemless component.The patient had a subacromial corticosteroid injection.Relative rest, activity modification, and nsaids were prescribed.Outcome is continuing.The patient is considering revision surgery.The study indicates that this is definitely not related to the devices or the procedure.Patient underwent revision surgery and was in stable condition.No further information known.

• Brand Name: EQUINOXE CAGE GLENOID L, POST AUG, LEFT
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 17608067
• Report Number: 1038671-2023-02033
• Device Sequence Number: 15072692
• Product Code: KWS
• UDI-Device Identifier: 10885862200983
• UDI-Public: 10885862200983
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2025

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: 01/28/2021
• Device Model Number: EQUINOXE CAGE GLENOID L, POST AUG, LEFT
• Device Catalogue Number: 314-13-24
• 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: Not provided
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 11/10/2025
• Date Device Manufactured: 02/01/2016
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 136 KG
• Patient Race: White