MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 42MM HUMERAL CONST LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-42-13
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 8 months and 8 days post a previous revision, the patient was revised again due to humeral liner dissociation.The patient was using an angle grinder when the liner dissociated.The glenosphere, liner, adapter tray, screw kit and locking screw were revised.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.Previous revision reported under 1038671-2023-02616.
Additional Manufacturer Narrative
Pending investigation.D10: 7322707 320-02-42 - rs expanded glenosphere 42mm, +4mm offset a659515 320-15-05 - eq rev locking screw a659516 320-15-05 - eq rev locking screw a566759 320-20-00 - eq reverse torque defining screw kit.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of humeral liner disassociation.The reported humeral liner disassociation may have been the result of incomplete seating of the liner during implantation, bone impingement, patient-related conditions, or any combination of these possibilities.However this cannot be confirmed as the devices were not returned for evaluation, and images and radiographs were not provided.

• Brand Name: EQUINOXE REVERSE 42MM HUMERAL CONST LINER +2.5
• 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: 19623711
• Report Number: 1038671-2024-02165
• Device Sequence Number: 6359948
• Product Code: KWT
• UDI-Device Identifier: 10885862086723
• UDI-Public: 10885862086723
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 11/08/2024

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: 320-42-13
• 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: 06/24/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2022
• 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: 72 YR
• Patient Sex: Male