MAUDE Adverse Event Report: EXACTECH, INC. SMALL GLENOID PLATE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	320-35-01
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	01/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: pending investigation.D10: 6685232 315-35-00 - glnd kwire, 6641610 320-10-00 - equinoxe reverse tray adapter plate tray +0, 6666075 320-15-05 - eq rev locking screw, 6707025 320-20-00 - eq reverse torque defining screw kit 6446897 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm, 6446899 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm, s097087 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, s107366 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, 6635600 320-31-36 - glenosphere, 36mm, 6685950 321-20-00 - equinoxe reverse shoulder drill kit.
Event or Problem Description
As reported, the patient had a left rtsa on (b)(6) 2020.A different surgeon scheduled a revision of the shoulder for (b)(6) 2024.Based on the x-ray it looked like the glenosphere baseplate came loose from the glenoid, and one screw broke.The surgeon ended up putting in an antibiotic spacer and plans to revise it back to a reverse at another date.There was no reported surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of compression screw fracture and glenoid loosening.However, the reported glenoid loosening could not be confirmed from the provided information.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and radiographs and were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: SMALL GLENOID PLATE
• 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: michael crader ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18656151
• Report Number: 1038671-2024-00170
• Device Sequence Number: 15469686
• Product Code: PHX
• UDI-Device Identifier: 10885862534866
• UDI-Public: 10885862534866
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 03/24/2025

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 Catalogue Number: 320-35-01
• 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: 01/21/2024
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2020
• 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 Sex: Female