MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	HUMERAL LINER, 40MM, +2.5
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: a798874 - 300-01-11 - equinoxe, humeral stem primary, press fit 11mm 7232012 -320-10-05 - equinoxe reverse tray adapter plate tray +5 a566398 - 320-20-00 - eq reverse torque defining screw kit additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 72 yo female patient, initial right shoulder implanted on (b)(6) 2023, underwent a revision procedure on (b)(6) 2024, approximately 2 months post the initial procedure.The patient was revised due to infection.The surgeon performed a washout and replaced the liner.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.The rep was unable to obtain any device images or x-rays.The explanted device is not available for return as it was disposed of by the hospital.No further information.
Additional Manufacturer Narrative
(h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision cannot be conclusively determined.The following sections have corrected information: h6: component code.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h3, h6, 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.A review of complaint history determined that no further action is required as no trends were identified.Neither corrections nor corrective actions are required because the possible risks related to this event are within the level assessed in the current risk management file and "infection¿ is listed in the product labeling [ifu 700-096-060 rev r].This reported failure does not appear to be a systemic issue.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision cannot be conclusively determined should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6 medical device problem code, types of investigation.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: 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.A review of complaint history determined that no further action is required as no trends were identified.Neither corrections nor corrective actions are required because the possible risks related to this event are within the level assessed in the current risk management file and "infection¿ is listed in the product labeling [ifu 700-096-060 rev r].This reported failure does not appear to be a systemic issue.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision cannot be conclusively determined.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18882554
• Report Number: 1038671-2024-00465
• Device Sequence Number: 2997188
• Product Code: PHX
• UDI-Device Identifier: 10885862535047
• UDI-Public: 10885862535047
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K180632
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/18/2025

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: 05/12/2025
• Device Model Number: HUMERAL LINER, 40MM, +2.5
• Device Catalogue Number: 320-40-03
• 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: 08/23/2024; 12/08/2025; 12/16/2025; 12/16/2025
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 08/23/2024; 12/17/2025; 12/18/2025; 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2020
• 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: 72 YR
• Patient Sex: Female