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

Catalog Number	300-30-06
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 3 months and 26 days post-operative of a left reverse total shoulder arthroplasty (rtsa), it was reported that the patient experienced loosening of the humeral stem.The patient underwent standard reverse revision for instability and the loose humeral stem.The humeral components were removed and the doctor implanted a competitor's humeral components.The patient was last known to be in stable condition following the event.No breakage or surgical delays were reported and the devices will not be returning as they were sent to pathology.
Additional Manufacturer Narrative
Pending investigation.Concomitants: 315-35-00 - glnd kwire, (b)(6).320-08-42 - glenosphere exp 42mm +4mm offset, (b)(6).320-15-05 - eq rev locking screw, (b)(6).320-15-07 - sup/post aug plate, l rs glenoid baseplate, (b)(6).320-20-00 - eq reverse torque defining screw kit, (b)(6).320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, (b)(6).320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, (b)(6).320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, (b)(6).320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm, (b)(6).320-42-00 - 145-deg pe 42mm hum liner +0, (b)(6).322-10-00 - humeral adapter tray, +0, (b)(6).531-55-88 - ergo gps 3.2mm drill kit sterile, (b)(6).531-78-20 - shouldr gps hex pins kit, (b)(6).A10012 - gps implant kit v2, (b)(6).
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may have been the result of joint instability or humeral loosening as reported.Potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not returned for evaluation and no product images or relevant clinical information was provided.H6: corrected medical device, component, and investigation clinical codes.

• Brand Name: EQUINOXE PRESERVE STEM 6MM
• 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, INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20630697
• Report Number: 1038671-2024-04292
• Device Sequence Number: 15435975
• Product Code: KWT
• UDI-Device Identifier: 10885862515742
• UDI-Public: 10885862515742
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K162726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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: 300-30-06
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 05/12/2025
• Date Device Manufactured: 12/07/2023
• 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: Required Intervention
• Patient Sex: Male