MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 8MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	300-30-08
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10): concomitant device(s): 300-10-15 - equinoxe replicator plate 1.5mm o/s: (b)(6).310-02-41 - equinoxe, humeral head tall, 41mm (alpha): (b)(6).300-20-02 - equinox square torque define screw drive kit: (b)(6).315-35-00 - glnd kwire: (b)(6).
Event or Problem Description
Approximately 5 year(s), 3 month(s) and 21 day(s) post-operative of a left tsa, it was reported via clinical study that the patient experienced aseptic glenoid loosening.Also reported was failed tsa, increased pain with adls, aseptic glenoid and humeral loosening, breakage of components, migration of anchor or screw.Approximately 3.5 years earlier, the patient experienced shoulder pain the radiates from the neck down to the elbow.Shoulder hurts with activity.Has ddd (degenerative disc disease) of c-spine on radiographs.The patient was recommended a follow-up appointment via telemedicine visit to discuss revision procedure.The outcome of this event is considered continuing and the clinical report indicates that this event is definitely related to the device(s) and possibly related to the procedure.
Additional Manufacturer Narrative
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/or the humeral component and the bone, which led to aseptic (non-infected) glenoid and humeral loosening respectively.Furthermore, the reported anatomic glenoid fracture and migration may have contributed to the event but cannot be confirmed.Potential contributions of user and patient-related 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.H6: corrected investigation clinical codes.

• Brand Name: EQUINOXE PRESERVE STEM 8MM
• 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: 20510359
• Report Number: 1038671-2024-04085
• Device Sequence Number: 7045025
• Product Code: HSD
• UDI-Device Identifier: 10885862515766
• UDI-Public: 10885862515766
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K162726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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: 300-30-08
• 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: 10/11/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 02/21/2025
• Date Device Manufactured: 11/03/2017
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: White