MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REPLICATOR PLATE 4.5MM O/S; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	300-10-45
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10): concomitant device(s): 300-01-11 - equinoxe, humeral stem primary, press fit 11mm, (b)(6); 300-20-02 - equinox square torque define screw drive kit, (b)(6); 310-01-44 - equinoxe, humeral head short, 44mm (alpha), (b)(6).
Event or Problem Description
Approximately 5 year(s), 3 month(s) and 28 day(s) post-operative of a right tsa, it was reported via clinical study that the patient experienced aseptic glenoid loosening.It was further stated that disassociation of other component - possible separation of poly from bone cage.Approximately 9 months and 21 days after the initial report of issue, the patient underwent a standard total revision with the removal of the replicator plate, torque screw, humeral head, and glenoid.The outcome of this event is considered resolved and the clinical report indicates that this event is definitely related to the device(s) and/or to the procedure.
Additional Manufacturer Narrative
1038671-2019-00094.Correction: please disregard this report as it was reported in error.Event was previously reported under report #1038671-2019-00094.

• Brand Name: EQUINOXE REPLICATOR PLATE 4.5MM O/S
• 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 ; 3523771140
• MDR Report Key: 20346437
• Report Number: 1038671-2024-03773
• Device Sequence Number: 7880152
• Product Code: KWS
• UDI-Device Identifier: 10885862079398
• UDI-Public: 10885862079398
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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: 12/02/2017
• Device Catalogue Number: 300-10-45
• 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: 09/12/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2012
• 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.
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 112 KG
• Patient Race: White