MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID SMALL, ALPHA; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	SMALL CAGED GLENOID
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the 72 y/o female patient had complained of pain for approximately 4 years (implants were put in 7-8 years ago).However, due to covid it had not been possible to x-ray/ct the patient so the surgeon is not fully clear what route of deterioration had been taking place.Patient first stage revision of a caged glenoid anatomic.All implants removed and replaced with a spacer.The patient's rotator cuff failed.Patient lost function.During the surgery the 3 x peripheral pegs and attached polyethylene were retrieved.The caged glenoid appeared to have significantly 'eroded' with possible erosion after being lodged under the humeral head.The medial calcar had also completely disappeared due to possible stress shielding.There was significant metalosis observed leading to the belief that this could have been the cage.There was no evidence of the cage being anywhere else (as per x-rays and ct's).The surgeon explored all reasonable options to find it but there was no sight of it.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photos and x-rays.The devices are not available for evaluation due to it is not hospital policy to release implants.Request has been made none the less.If approved, they will be collected and sent to gv.
Additional Manufacturer Narrative
Section d10: concomitant products 41mm head.4.5mm replicator plate.11mm humeral stem.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Corrections: h6: health effect / clinical code.Additional information: d9 - device return.H3 - the revision reported was likely the result of failure of the patient¿s rotator cuff and 4 years of reported pain.The glenoid component was returned fractured with the center cage missing.The cause and sequence of events cannot be determined because no sequential, pre-revision radiographs were provided.H6 - medical device problem code, health effect / clinical code, investigation codes.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1/d2a/d2b, h4, h6.Mdr section codes updated/corrected: a.The revision reported was likely the result of failure of the patient¿s rotator cuff and four years of reported pain.The glenoid component was returned fractured with the center cage missing.The cause and sequence of events cannot be determined because no sequential, pre-revision radiographs were provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE CAGE GLENOID SMALL, ALPHA
• 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 ; 3525541928
• MDR Report Key: 19154225
• Report Number: 1038671-2024-00927
• Device Sequence Number: 7862397
• Product Code: KWS
• UDI-Device Identifier: 10885862172679
• UDI-Public: 10885862172679
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SMALL CAGED GLENOID
• Device Catalogue Number: 314-13-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 09/04/2024; 05/12/2025
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 09/11/2024; 05/12/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female