MAUDE Adverse Event Report: EXACTECH, INC. SMALL SUPERIOR/POSTERIOR AUG GLENOID PLATE,LEFT; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	320-35-07
Medical Device Problem Codes	Mechanical Problem (1384); Use of Device Problem (1670)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Insufficient Information (4580)
Date of Event	01/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient's left knee was revised approximately 9 months post initial operation.It was stated that the implant had failed and the inferior screw had broken.Upon revision, found out that the implant was put in upside down.Surgeon removed as much of the broken screw as he could, but part of the screw was still left fragmented in the patient.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
D10 - concomitant devices: 320-20-34 - eq rev cmprss scrw lck cap kit, 4.5 x 34mm: (b)(6).320-20-26 - eq rev cmprss scrw lck cap kit, 4.5 x 26mm: (b)(6).320-20-26 - eq rev cmprss scrw lck cap kit, 4.5 x 26mm: (b)(6).320-31-40 - glenosphere, 40mm: (b)(6).320-40-03 - 145-deg pe 40mm hum liner +2.5: (b)(6).320-10-00 - eq rev tray adapter plate tray +0: (b)(6).320-20-00 - eq rev torque defining screw kit: (b)(6).H3: the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
The revision reported was likely the result of a screw fracture.Implant orientation may have been a contributing factor to in-vivo stress on the screw leading to fracture, but the potential contributions of this user-related issue and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and relevant clinical information were not provided.

• Brand Name: SMALL SUPERIOR/POSTERIOR AUG GLENOID PLATE,LEFT
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21364476
• Report Number: 1038671-2025-00853
• Device Sequence Number: 8482091
• Product Code: PHX
• UDI-Device Identifier: 10885862534910
• UDI-Public: 10885862534910
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• 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,Followup
• Report Date (Section B): 07/22/2025

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: 320-35-07
• 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: 01/20/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 07/22/2025
• Date Device Manufactured: 12/12/2023
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male