MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 42MM HUM LINER +2.5; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	322-42-03
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6) 300-10-45 - equinoxe replicator plate 4.5mm o/s.(b)(6) 300-20-02 - equinox square torque define screw drive kit.(b)(6) 300-30-10 - equinoxe preserve stem 10mm.(b)(6) 310-01-53 - equinoxe, humeral head short, 53mm (beta).(b)(6) 314-23-14 - laser cage glenoid large, beta.(b)(6) 321-52-09 - 3.2mm k-wire, trocar tip.(b)(6) 300-10-45 - equinoxe replicator plate 4.5mm o/s.(b)(6) 300-20-02 - equinox square torque define screw drive kit.(b)(6) 300-30-10 - equinoxe preserve stem 10mm.(b)(6) 310-01-53 - equinoxe, humeral head short, 53mm (beta).(b)(6) 314-23-14 - laser cage glenoid large, beta.(b)(6) 321-52-09 - 3.2mm k-wire, trocar tip.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2025-02287.Customer has indicated that the product is in process of being returned for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that this patient's right shoulder was revised approximately 1 year 5 months post second right shoulder revision.The patient experienced grinding and upon dissection the surgeon appreciated the polyethylene component disassociated from the tray and was floating allowing the tray and glenoid to grind.All components of the construct except the humeral stem were revised to exactech components.No medical or surgical interventions were reported.No additional information is available.

• Brand Name: 145-DEG PE 42MM HUM LINER +2.5
• 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 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 22198890
• Report Number: 1038671-2025-02288
• Device Sequence Number: 9227676
• Product Code: PHX
• UDI-Device Identifier: 10885862593924
• UDI-Public: 10885862593924
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K223833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 06/12/2025

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: 322-42-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male