MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-20-22
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Aseptic loosening (4883)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant devices: 308-01-06 - 6x80mm distal stem modular cemented: (b)(6), 320-36-13 - 145-deg pe 36mm const hum liner +2.5: (b)(6), 320-35-02 - small superior augment glenoid plate: (b)(6), 320-32-36 - expanded gleno, 36mm, for small reverse: (b)(6), 320-10-00 - equinoxe rev tray adapter plate tray +0: (b)(6), 320-15-05 - eq rev locking screw: (b)(6), 308-05-17 - distal fixation ring ha 17.5: (b)(6), 308-09-12 - small prox body +12.5: (b)(6), 308-15-12 - taper locking screw 12.5: (b)(6), 320-20-22 - eq rev comp screw lck cap kit, 4.5 x 22mm: (b)(6), 320-20-22 - eq rev comp screw lck cap kit, 4.5 x 22mm: (b)(6), 320-20-26 - eq rev comp screw lck cap kit, 4.5 x 26mm: (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
It was reported that the patient underwent an initial reverse total shoulder replacement on the right side with a competitor's devices.Subsequently, the patient was revised to exactech devices and has experienced disassociation of the glenosphere component, approximately 2 years after the shoulder revision.It was reported, the patient reached behind car seat and immediately experienced pain and the shoulder felt "stuck." this resulted in loosening of baseplate screws and humeral stem lucency.As a result, after the revision to exactech devices, the patient reportedly underwent an additional right shoulder revision but no official date was stated or could be located.No further impact to the patient was reported.No other information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d6b, h6.Mdr section codes updated/corrected: b, c, d, e, f, g.The revision reported may have been the result of the glenoid baseplate and distal stem loosening as reported.Also, the reported loosening of the implants may have caused the reported pain.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 no radiograph, images, or clinical information was provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM
• 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: 22135431
• Report Number: 1038671-2025-02230
• Device Sequence Number: 7356921
• Product Code: KWT
• UDI-Device Identifier: 10885862086532
• UDI-Public: 10885862086532
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

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 Catalogue Number: 320-20-22
• 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: 05/13/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 10/29/2025
• Date Device Manufactured: 02/21/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White