MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 46MM HUMERAL LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE REVERSE 46MM HUMERAL LINER +0
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	11/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00 / serial#: (b)(4), equinoxe reverse 46mm glenosphere (cat# 320-01-46 / serial#: (b)(4), eq reverse torque defining screw kit (cat# 320-20-00 / serial#: (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the equinoxe shoulder study, approximately five years post initial right side tsa, the 62 y/o male patient was lifting a sign overhead and had sharp pain.Patient experienced disassociation of polyethylene.Patient had a revision approximately a month later and the event was resolved.
Additional Manufacturer Narrative
(h3 the revision reported may have been the result of incomplete seating of the liner during implantation, bone impingement, patient-related conditions, an unreported post traumatic event, or any combination of these possibilities, which led to humeral liner disassociation.However, this cannot be confirmed as the devices were not returned for evaluation and images/radiographs were unable to be obtained.The most probable root cause associated with the reported event of ¿humeral liner disassociation¿ is associated with post-operative disassociation of the humeral liner component from the humeral adapter tray/plate.Do not use for humeral liner seating difficulty.
Event or Problem Description
It was reported that the patient underwent an initial right reverse total shoulder arthroplasty.Subsequently, it was reported that the patient experienced pain and disassociation of the humeral liner from the humeral tray.As a result, the patient underwent a right shoulder revision surgery approximately 5 years after initial implantation.No further patient impact reported.No further information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b3, b5, d8, d10, g1, h6 - health effect - clincal code, component code, type of investigation, investigation findings, investigation conclusions and h11.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h6 - type of investigation and h11.The revision reported may have been the result of incomplete seating of the liner during implantation, bone impingement, patient-related conditions, an unreported post traumatic event, or any combination of these possibilities, which led to humeral liner disassociation.However, this cannot be confirmed as the devices were not returned for evaluation and images/radiographs were unable to be obtained.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE REVERSE 46MM HUMERAL LINER +0
• 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 ; 3523771140
• MDR Report Key: 15874689
• Report Number: 1038671-2022-01522
• Device Sequence Number: 5486998
• Product Code: KWT
• UDI-Device Identifier: 10885862086730
• UDI-Public: 10885862086730
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/18/2026

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 Expiration Date: 02/22/2022
• Device Model Number: EQUINOXE REVERSE 46MM HUMERAL LINER +0
• Device Catalogue Number: 320-46-00
• 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: 11/09/2022
• Supplement Date Received by Manufacturer: 06/26/2023; 01/26/2026; 03/16/2026
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 07/25/2023; 02/12/2026; 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2017
• 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: EQ REV COMPRESS SCREW.; EQ REV COMPRESS SCREW.; EQ REV GLENOID PLATE.; EQ REV LOCKING SCREW.; EQUINOXE PRESERVE STEM 8MM.; EQUINOXE REVERSE SHOULDER DRILL KIT.; SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Race: White