MAUDE Adverse Event Report: EXACTECH, INC. RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Unspecified Infection (1930); Insufficient Information (4580)
Date of Event	12/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 67 yo male patient, initial right shoulder implanted on (b)(6) 2022, underwent a revision procedure on (b)(6) 2023, approximately 1 year 8 months post the initial procedure.The report indicated the glenoid was loose and infection was suspected.The patient was revised to a 300-10-15 equinoxe replicator plate 1.5mm o/s, 300-20-02 equinoxe square torque define screw, and 310-03-53 equinoxe humeral head expanded 53mm.There were no device breakages or surgical delays during the procedure.No x rays or patient history was able to be obtained.The patient was last known to be in stable condition following the event.No devices are returning for analysis due to the hospital policy.Device images were provided.No further information.
Additional Manufacturer Narrative
D10: concomitants: 6977672 - 00-30-14 - equinoxe preserve stem 14mm.6886836 - 320-08-42 - glenosphere exp 42mm +4mm offset.7264988 - 320-10-00 - equinoxe reverse tray adapter plate tray +0.7068896 - 320-15-04 - rs glenoid plate r post aug, 8 deg, right.7253803 - 320-15-05 - eq rev locking screw.7271230 - 320-20-00 - eq reverse torque defining screw kit.S336664 - 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.S342780 - 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.S344269 - 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.S302526 - 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.S214372 - 320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm.6543972 - 320-42-13 - 145-deg pe 42mm const hum liner +2.5.6893070 - 321-20-00 - equinoxe reverse shoulder drill kit.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b5, d1, d4, g1, h1, h6: clinical code, component code, investigation types, investigation findings and investigation conclusions.The revision reported was likely the result of loosening of the glenoid baseplate, and scapular notching leading to prosthesis wear of the humeral liner.Potential contributions of user or patient-related considerations to the event could not be assessed, and the sequence of events and root cause cannot be determined because the revised components were not returned for evaluation and no radiographs were provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a male patient, had an initial right shoulder implanted and then underwent a revision procedure, approximately 1 year 8 months post the initial procedure.The report indicated the glenoid was loose and infection was suspected.The patient was revised to a 300-10-15 equinoxe replicator plate 1.5mm o/s, 300-20-02 equinoxe square torque define screw, and 310-03-53 equinoxe humeral head expanded 53mm.There were no device breakages or surgical delays during the procedure.No x rays or patient history was able to be obtained.The patient was last known to be in stable condition following the event.No devices are returning for analysis due to the hospital policy.Device images were provided.No further information.

• Brand Name: RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-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 ; 3523164164
• MDR Report Key: 18493419
• Report Number: 1038671-2024-00077
• Device Sequence Number: 14341175
• Product Code: KWS
• UDI-Device Identifier: 10885862186690
• UDI-Public: 10885862186690
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 01/08/2026

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 Model Number: RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT
• Device Catalogue Number: 320-15-04
• 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: 12/13/2023
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 01/08/2026
• Date Device Manufactured: 08/11/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male