MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	300-01-11
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Fall (1848)
Date of Event	12/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): 300-50-45 - 4.5mm short rep plate: (b)(6).300-20-02 - equinox square torque define screw drive kit: (b)(6).310-00-47 - xs humeral head, 47mm xs offset humeral head: (b)(6).620-00-02 - platelet rich plasma kit with spray tips: (b)(6).620-12-02 - accelerate prp 60 ml & acd-a: (b)(6).
Event or Problem Description
Approximately 3 year(s), 7 month(s) and 30 day(s) post-operative of a left tsa, it was reported via clinical study that the patient experienced aseptic glenoid loosening.It was reported as both tsa stem and glenoid loose - possibly due to fall.The patient underwent standard total revision, and the outcome of this event is considered resolved.The clinical report indicates that this event is possibly related to the device(s) and/or to the procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of an insufficient bond between the glenoid component and the bone and the humeral component and the bone, which led to aseptic (non-infected) glenoid and humeral loosening respectively.Furthermore, the reported fall may have contributed to the anatomic glenoid and humeral loosening but cannot be confirmed.Potential contributions of user considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not 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, PRESS FIT 11MM
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 20184088
• Report Number: 1038671-2024-03427
• Device Sequence Number: 15686231
• Product Code: HSD
• UDI-Device Identifier: 10885862079312
• UDI-Public: 10885862079312
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2025

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: 07/29/2024
• Device Catalogue Number: 300-01-11
• 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: 08/26/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 02/14/2025
• Date Device Manufactured: 07/31/2014
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Race: White