MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 6MM; PROSTHESIS, SHOULDER, SEMI-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	04/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial right tsa.Subsequently, the patient reported "feeling loose and unstable" and that the implant was "rocking".As a result, the patient underwent a right shoulder revision approximately 3 weeks after initial implantation.No further patient impact reported.
Additional Manufacturer Narrative
D10: 322-10-00 - humeral adapter tray, +0; (b)(6), 322-36-00 - 145-deg pe 36mm hum liner +0; (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), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm; (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), 320-31-36 - glenosphere, 36mm; (b)(6), 320-35-04 - small posterior augment glenoid plate, right; (b)(6), 321-20-00 - equinoxe reverse shoulder drill kit; (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined that this device did not cause or contribute to the reported event.As a result, this complaint event is no longer considered reportable by exactech and this report may be disregarded.
Event or Problem Description
It was reported that the patient experienced a fall.

• Brand Name: EQUINOXE PRESERVE STEM 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 22306564
• Report Number: 1038671-2025-02335
• Device Sequence Number: 7937327
• Product Code: KWS
• UDI-Device Identifier: 10885862515742
• UDI-Public: 10885862515742
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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: 06/06/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female