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 Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Joint Dislocation (2374); Medical device site infection (4845); Joint effusion (4849)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 300-01-11 - equinoxe, humeral stem primary, press fit 11mm: (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).320-15-05 - 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).320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm: (b)(6).320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm: (b)(6).531-20-00 - shldr gps rvrs drill kit: (b)(6).531-78-20 - shouldr gps hex pins kit: (b)(6).A10012 - gps implant kit v2: (b)(6).No device was returned for evaluation; pre-revision radiograph images were provided; however, the reported event was unable to be confirmed.The review identified that there appears to be a fracture plate and screws likely from the reported orif procedure.Based on the image provided, the reported dislocations could not be confirmed.An image of the revised humeral liner was provided.There appears to be wear on the inferior lip of the humeral liner.This may have been due to impingement with the scapula and/or the reported dislocations.An image was provided of all the revised components.The devices appear unremarkable for revised components aside from the wear noted on the humeral liner.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from an infection and subsequent effusion.The reason for the infection cannot be conclusively determined but may be related to a patient condition and/or a prior surgical procedure.Additionally, the reported dislocations may be due to soft tissue imbalance, patient anatomy, implant positioning, and/or implant selection.The observed wear may be due to impingement and/or from the reported dislocations.However, this cannot be confirmed based on the available information and the devices were not available for evaluation.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 6 years and 5 months post the initial left reverse total shoulder arthroplasty, the patient presented with effusion following a fractured scapula spine open reduction and internal fixation and multiple dislocations.The joint was opened and frank pus was observed behind the glenosphere.All components were removed and a cement spacer was implanted.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.

• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 23708123
• Report Number: 1038671-2025-03478
• Device Sequence Number: 10670341
• Product Code: KWT
• UDI-Device Identifier: 10885862086655
• UDI-Public: 10885862086655
• 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: 2019
• 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
• Report Date (Section B): 12/03/2025

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: 06/14/2023
• 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: 11/26/2025
• Initial Report FDA Received Date: 12/03/2025
• Date Device Manufactured: 06/18/2018
• 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; Hospitalization
• Patient Sex: Female