MAUDE Adverse Event Report: EXACTECH, INC. CENTRAL SCREW BASEPLATE STANDARD; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	320-55-01
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Aseptic loosening (4883)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10: 300-01-11 - equinoxe, humeral stem primary, press fit 11mm.320-36-00 - 145-deg pe 36mm hum liner +0.322-10-00 - humeral adapter tray, +0.320-55-99 - csb glenosphere screw: b371603.320-55-01 - central screw baseplate standard: b275831.320-55-35 - central screw baseplate, 35mm: b494081.320-31-36 - glenosphere, 36mm.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.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
It was reported via clinical study that the patient underwent an initial total shoulder arthroplasty.Subsequently, the patient experienced pain with no associated trauma.X-rays were taken, showing signs of aseptic glenoid loosening.The device remains implanted at this time.Additional imaging will be performed at follow up appointment; therefore, the patient's outcome is considered continuing.

• Brand Name: CENTRAL SCREW BASEPLATE STANDARD
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24315500
• Report Number: 1038671-2026-00136
• Device Sequence Number: 14848825
• Product Code: PHX
• UDI-Device Identifier: 10885862625618
• UDI-Public: 10885862625618
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K233482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 02/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 320-55-01
• 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: 01/23/2026
• Initial Report FDA Received Date: 02/11/2026
• Date Device Manufactured: 10/03/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Race: White