MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 38MM HUM LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-38-00
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Osteolysis (2377); Insufficient Information (4580)
Date of Event	01/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 76 yo male patient, initial shoulder implanted in (b)(6) 2016, underwent a revision procedure in (b)(6) 2025, approximately 8 years 6 months post the initial procedure.Reason for the revision is unknown.The surgeon did not provide any details.Everything was removed.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays or device images were able to be obtained.The explanted devices are not available for return as they were disposed of by the customer.No further information.
Additional Manufacturer Narrative
D10: concomitants: (b)(6) 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.(b)(6) 320-38-00 - equinoxe reverse 38mm humeral liner +0.(b)(6) 315-35-00 - glnd kwire.(b)(6) 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(6) 300-01-13 - equinoxe, humeral stem primary, press fit 13mm.(b)(6) 321-20-00 - equinoxe reverse shoulder drill kit.(b)(6) 320-01-38 - equinoxe reverse 38mm glenosphere.(b)(6) 320-15-05 - eq rev locking screw.(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) 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6) 320-15-01 - eq rev glenoid plate.(b)(6) 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h3 - the reason for the revision reported cannot be confirmed from the information provided but may be due to wear, loosening, infection, fracture, instability, or patient related factors.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.H6-investigation codes the following sections were corrected: h6-investigation codes 4118, 3233, 11 no longer applies.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: d1, d4.H4, h6.The reason for the revision cannot be confirmed from the information provided but may be due to wear and subsequent osteolysis over the course of 9.5 years of implantation.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information 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: 145-DEG PE 38MM HUM LINER +0
• 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 21454185
• Report Number: 1038671-2025-01173
• Device Sequence Number: 7761746
• Product Code: KWT
• UDI-Device Identifier: 10885862086655
• UDI-Public: 10885862086655
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2025

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 Expiration Date: 01/20/2021
• Device Catalogue Number: 320-38-00
• 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: 02/05/2025
• Supplement Date Received by Manufacturer: 05/21/2025; 07/28/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 05/29/2025; 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2016
• 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: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male