MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 38MM HUM LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-38-03
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	12/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 - concomitants: (b)(6), 300-01-13 - equinoxe, humeral stem primary, press fit 13mm; (b)(6), 315-35-00 - glnd kwire; (b)(6), 320-01-38 - equinoxe reverse 38mm glenosphere; (b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0; (b)(6), 320-15-01 - eq rev glenoid plate; (b)(6), 320-20-00 - eq reverse torque defining screw kit; (b)(6), 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm; (b)(6), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm; (b)(6), 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm; (b)(6), 321-20-00 - equinoxe reverse shoulder drill kit.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.
Event or Problem Description
It was reported that this patient's shoulder was revised approximately 1 year 6 months post initial operation.It was suspected that the glenosphere screw had backed out.However, surgeon had found that the glenosphere screw had broken into the glenoid baseplate.The screw had subsequently backed out and wearing the humeral poly causing lysis.After removal, surgeon re inserted a long peg baseplate and new implants as the stem was well fixed.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 reason for the revision was likely due to fracture of the glenosphere locking screw leading to unintended contact with the liner and subsequent polyethylene wear.The reason for the fracture could not be determined from the information provided, but may be related to incomplete seating of the locking screw and/or partially disassembly of the device.However, this cannot be confirmed from the information provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: 145-DEG PE 38MM HUM LINER +2.5
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 21263633
• Report Number: 1038671-2025-00522
• Device Sequence Number: 4336226
• Product Code: KWT
• UDI-Device Identifier: 10885862086662
• UDI-Public: 10885862086662
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 05/02/2025

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 Expiration Date: 12/08/2025
• Device Catalogue Number: 320-38-03
• 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: 01/13/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2020
• 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 H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male