MAUDE Adverse Event Report: EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE REVERSE 46MM HUMERAL LINER +2.5
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 66 yo male patient, initial left reverse shoulder implanted on (b)(6) 2023, underwent a revision procedure on (b)(6) 2024.The patient presented to the surgeon due to a dislocation.The surgeon scheduled a revision.During the procedure, the surgeon removed the liner and glenosphere, and implanted a std 46 glenosphere and then trialed a +0, +2.5, +5 46 liner and found that the +5 build up to be the most stable.He implanted the final implants and reduced the shoulder.There were no surgical delays or device breakages during the event.No x-rays were provided.The patient was last known to be in stable condition following the event.The explanted devices are not available for analysis.The hospital kept them.Device images were provided.No further information.
Additional Manufacturer Narrative
D10: concomitants: 7167729 - 300-30-08 - equinoxe preserve stem 8mm a751583 - 315-35-00 - glnd kwire a768084 - 320-10-00 - equinoxe reverse tray adapter plate tray +0 a795912 - 320-10-46 - glenosphere 46x21mm inset a816301 - 320-15-02 - rs glenoid plate sup aug, 10 deg a750358 - 320-15-05 - eq rev locking screw a771406 - 320-20-00 - eq reverse torque defining screw kit s446188 - 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm s468649 -320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm s418002 - 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
The cause of the patient¿s shoulder dislocation and subsequent revision reported cannot be conclusively determined; however, it may be due to soft tissue imbalance, patient anatomy, implant positioning, and/or implant selection.Dislocation is a known risk, as outlined in the ifu.

• Brand Name: SPECIFIC DEVICE NOT REPORTED
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523782617
• MDR Report Key: 18882331
• Report Number: 1038671-2024-00463
• Device Sequence Number: 16916270
• Product Code: KWT
• UDI-Device Identifier: 10885862086747
• UDI-Public: 10885862086747
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 06/05/2025

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: 07/05/2025
• Device Model Number: EQUINOXE REVERSE 46MM HUMERAL LINER +2.5
• 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: Not provided
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 06/05/2025
• Date Device Manufactured: 07/07/2020
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male