MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	300-01-09
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h3, h6: type of investigation, investigation findings, and investigation conclusions.The following sections were corrected: h6 clinical code.H3: the revision reported may be the result of the humeral loosening as reported.However, the loosening cannot be confirmed and any potential contributions from manufacturing, user, or patient-related contributing factors to the event cannot be evaluated as the devices were not returned for evaluation and no images or radiographs were provided.
Event or Problem Description
It was reported that the patient underwent an initial reverse total shoulder replacement with competitor's devices on the right side and then was revised to exactech devices.Subsequently, the patient experienced mobilization of the prosthetic stem, pain, and functional impotence.As a result, approximately 2 years after implantation of exactech devices, the patient underwent an additional right shoulder revision.No further impact to the patient was reported.No other information is available.
Additional Manufacturer Narrative
(d10) concomitant devices: 320-38-03 - 145-deg pe 38mm hum liner +2.5, 320-10-00 - equinoxe reverse tray adapter plate tray +0, 320-01-38 - equinoxe reverse 38mm glenosphere, 320-15-01 - eq rev glenoid plate, 320-15-05 - eq rev locking screw.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.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM
• Common Device Name: PROSTHESIS, SHOULDER, NON-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: 22039978
• Report Number: 1038671-2025-02083
• Device Sequence Number: 8898636
• Product Code: KWT
• UDI-Device Identifier: 10885862079305
• UDI-Public: 10885862079305
• 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: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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 Catalogue Number: 300-01-09
• 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: 05/16/2023
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 07/03/2025
• 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: Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White