MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, CEMENTED 6MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	302-01-06
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10): concomitant device(s): 320-01-38 - equinoxe reverse 38mm glenosphere: (b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0: (b)(6) 320-15-01 - eq rev glenoid plate: (b)(6) 320-15-05 - eq rev locking screw: (b)(6) 320-20-00 - eq reverse torque defining screw kit: (b)(6).320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm: (b)(6) 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm: (b)(6) 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm: (b)(6) 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm: (b)(6) 320-38-00 - equinoxe reverse 38mm humeral liner +0: (b)(6).
Event or Problem Description
Approximately 7 years, 2 months, 8 days post-operative of a right rtsa, it was reported via clinical study that the patient experienced aseptic humeral loosening (ancient humeral fracture).No actions were taken for this patient and it was further noted last x-ray received may 2024 - complete humeral loosening but patient is now too old for revision surgery.The outcome of this event is considered resolved and the clinical report indicates that this event is definitely not related to the device(s) and/or related to the procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The event reported was likely the result of an insufficient bond between the humeral stem and the bone, which led to aseptic (non-infected) humeral loosening.This may have been related to the patient¿s bone fracture, which occurred prior to implantation of exactech components.The extent and root cause of the humeral loosening could not be determined as the devices have not been revised, and no images or radiographs were provided.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, CEMENTED 6MM
• 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: 20385419
• Report Number: 1038671-2024-03836
• Device Sequence Number: 15090348
• Product Code: KWS
• UDI-Device Identifier: 10885862081971
• UDI-Public: 10885862081971
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/23/2022
• Device Catalogue Number: 302-01-06
• 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: 09/24/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2012
• 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: 84 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Race: White