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 Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.D10: a523208 300-01-13 - equinoxe, humeral stem primary, press fit 13mm; a605790 320-10-00 - equinoxe reverse tray adapter plate tray +0; a599681 320-15-05 - eq rev locking screw; a561497 320-20-00 - eq reverse torque defining screw kit; s357111 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm; s436115 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm; s449539 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm; s450984 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm; a507514 320-32-36 - expanded glenosphere, 36mm, for small reverse; a266043 320-36-03 - 145-deg pe 36mm hum liner +2.5; a480985 321-52-07 - 3.2mm drill bit sterile.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
As reported, approximately 1 year and 5 months post the initial left total shoulder arthroplasty, the patient's baseplate loosened and the patient was revised.There was no reported breakage of a device or 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 following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, d, g.The revision reported may be the result of the glenoid loosening as reported.However, the loosening cannot be confirmed and any potential contributions from manufacturing, user, or patient-related contributing factors to the event cannot be evaluated as no radiograph, images, or clinical information was 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 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, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21442756
• Report Number: 1038671-2025-01145
• Device Sequence Number: 18127549
• Product Code: PHX
• UDI-Device Identifier: 10885862534910
• UDI-Public: 10885862534910
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 05/15/2025

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: 320-35-07
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 02/23/2025
• Supplement Report FDA Received Date: 05/15/2025
• Date Device Manufactured: 05/11/2023
• 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 H11.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 69 YR
• Patient Sex: Unknown