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 Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial anatomic shoulder replacement on the right side.Subsequently, the patient experienced possible aseptic loosening of the glenoid component, displaced poly.As a result, approximately five years and eleven months post-surgery, diagnostic imaging to confirm loosening was ordered.This event is considered continuing.No further impact to the patient was reported.No additional information is available at this time.
Additional Manufacturer Narrative
D10: 300-30-07 - equinoxe preserve stem 7mm: (b)(6).310-02-50 - equinoxe, humeral head tall, 50mm (beta): (b)(6).300-10-45 -equinoxe replicator plate 4.5mm o/s: (b)(6).The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h6.The reported event was unable to be confirmed due to limited information received from the customer.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from glenoid loosening.However, the failure and potential contributions from manufacturing, patient, or user-related issues to the event cannot be confirmed.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b2, b3, b5, d6b, h6.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
Ct scan confirmed loosening of the glenoid component.As a result, six years and eight months post-surgery the patient underwent a revision.The outcome is considered resolved.No further impact to the patient was reported.No additional information is available at this time.

• 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, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 22421649
• Report Number: 1038671-2025-02431
• Device Sequence Number: 8680269
• 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: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2025

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 Expiration Date: 01/09/2023
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 09/19/2025; 10/17/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 09/23/2025; 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2018
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Hispanic