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

Catalog Number	314-13-14
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Aseptic loosening (4883)
Date of Event	10/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial total shoulder replacement on the right side.Subsequently, the patient experienced aseptic glenoid loosening.Glenoid component problem most consistent with loosening and possibly polyethylene wear.As a result, almost 6 years after initial replacement, the patient underwent a right shoulder revision.No further impact to the patient was reported.No other information is available.
Additional Manufacturer Narrative
(d10) concomitant devices: 300-01-15 - eqhumeral stem primary, press fit 15mm: (b)(6), 300-10-45 - eq replicator plate 4.5mm o/s: (b)(6), 300-20-02 - eq sq torque define screw drive kit: (b)(6), 310-03-47 - eq humeral head expanded, 47mm (beta): (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
The glenoid failure reported may be the result of the aseptic glenoid loosening as reported.However, the failure cannot be confirmed as no relevant clinical information, images, or radiographs were provided.Potential contributions of patient, or user-related issues to the event cannot be determined from the reported information.H6: corrected health effect, medical device, component, and investigation clinical codes.H10 related report numbers: 1038671-2023-01802, 1038671-2025-01778, 1038671-2023-01130 and 1038671-2025-01713.

• Brand Name: EQUINOXE CAGE GLENOID LARGE, BETA
• 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; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21746012
• Report Number: 1038671-2025-01712
• Device Sequence Number: 14418496
• Product Code: KWS
• UDI-Device Identifier: 10885862172716
• UDI-Public: 10885862172716
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

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: 01/08/2019
• Device Catalogue Number: 314-13-14
• 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: 03/18/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 06/20/2025
• Date Device Manufactured: 01/13/2014
• 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 H11
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 108 KG
• Patient Race: White