MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, CEMENTED 10MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	302-01-10
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient underwent a right shoulder replacement.Subsequently, the patient reported pain during movement of their shoulder.Patient was admitted for scheduled surgery for revision of the right shoulder prosthesis.The stem was fully mobilized, and the glenosphere was removed.The metal back demonstrated excellent stability.The medullary canal was then prepared, and a new glenosphere and cemented stem were implanted.The implant exhibited excellent stability following placement.No further information is available.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, CEMENTED 10MM
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 25666587
• Report Number: 1038671-2026-00813
• Device Sequence Number: 14894120
• Product Code: KWS
• UDI-Device Identifier: 10885862081995
• UDI-Public: 10885862081995
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

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: 10/17/2023
• Device Catalogue Number: 302-01-10
• 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: 06/09/2026
• Initial Report FDA Received Date: 06/30/2026
• Date Device Manufactured: 10/23/2013
• 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: 79 YR
• Patient Sex: Female