MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL HEAD SHORT, 50MM (BETA); PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE, HUMERAL HEAD SHORT, 50MM (BETA)
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	11/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant product: humeral stem or stemless (cat#: 300-01-11), replicator plate (cat#: 300-10-15), glenoid (cat#: 314-02-14).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the equinoxe shoulder study, approximately three years post initial right tsa, the 61 y/o male patient developed pain and x ray showed humeral loosening.Patient had a revision surgery on (b)(6) 2023.Per clinical report, the reported event is possibly related to the device and to the procedure.
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of an insufficient bond between the humeral components and the bone, which led to aseptic (non-infected) humeral loosening.The extent and root cause of the humeral loosening could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.
Additional Manufacturer Narrative
After additional review of information and an update to the investigation, the following sections d10, g1, g3, g6, h1, h2, and h6 have been updated accordingly.(d10) concomitant devices: humeral stem or stemless (cat# 300-01-11), replicator plate (cat# 300-10-15), glenoid (cat# 314-02-14).

• Brand Name: EQUINOXE, HUMERAL HEAD SHORT, 50MM (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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 17814826
• Report Number: 1038671-2023-02366
• Device Sequence Number: 6125019
• Product Code: KWS
• UDI-Device Identifier: 10885862083890
• UDI-Public: 10885862083890
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2024

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: EQUINOXE, HUMERAL HEAD SHORT, 50MM (BETA)
• Device Catalogue Number: 310-01-50
• 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: 09/04/2023
• Supplement Date Received by Manufacturer: 12/18/2023; 11/04/2024
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 04/18/2024; 11/14/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 112 KG
• Patient Race: White