MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL HEAD TALL, 47MM (BETA); PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	310-02-47
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994); Joint Laxity (4526); Muscle/Tendon Damage (4532)
Date of Event	05/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant devices: 300-30-06 - equinoxe preserve stem 6mm: (b)(6), 300-10-45 - equinoxe replicator plate 4.5mm o/s: (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.
Event or Problem Description
Approximately 9 month(s) and 17day(s) post-operative of a revised left tsa, it was reported via clinical study that the patient experienced a subscapularis tear.Significant weakness, pain with internal rotation; instability were reported for the patient.The patient underwent a standard hemi with preserve stem revision with the reported removal of the humeral head.It was previously reported that the patient underwent a revision due to loosening and disassociation of the polyethylene captured on report 1038671-2024-03028; and a revision prior to that for unknown reason was also captured on report 1038671-2025-01514.This was reported through clinical trial study data collection activities, no device return is anticipated, and no other information is available at this time.
Additional Manufacturer Narrative
The reason for the revision reported was likely due to rotator cuff deterioration and subsequent superior migration of the humeral head resulting in prosthesis wear of the glenoid component.The reason for the rotator cuff failure cannot be conclusively determined but may be related to an underlying patient condition, component sizing or positioning issues, or a combination of the above.The reason for the reported instability cannot be conclusively determined; however, it may be due to soft tissue imbalance, rotator cuff failure, patient anatomy, implant positioning, and/or implant selection.Instability is a known risk, as outlined in the ifu.H6: corrected health effect, medical device, component, and investigation clinical codes.H10: 1038671-2024-03028, 1038671-2025-01514, 1038671-2025-01516.

• Brand Name: EQUINOXE, HUMERAL HEAD TALL, 47MM (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: 21561666
• Report Number: 1038671-2025-01515
• Device Sequence Number: 9170451
• Product Code: KWS
• UDI-Device Identifier: 10885862083944
• UDI-Public: 10885862083944
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: 10/05/2026
• Device Catalogue Number: 310-02-47
• 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: 02/17/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 08/13/2025
• Date Device Manufactured: 10/05/2016
• 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: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Race: Black Or African American