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	Erosion (1750); Insufficient Information (4580)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 2 months and 15 days post the initial right reverse total shoulder arthroplasty, the patient was revised.It appeared the glenosphere had loosened/not been implanted properly.Wear evidences were shown on the liner and humerus.Everything was removed and a new reverse shoulder 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.
Additional Manufacturer Narrative
D10: (b)(6) - 300-30-08 - equinoxe preserve stem 8mm.(b)(6) - 315-35-00 - glnd kwire.(b)(6) - 320-38-00 - equinoxe reverse 38mm humeral liner +0.(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) - 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6) - 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(6) - 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.(b)(6) - 321-52-07 - 3.2mm drill bit sterile.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: g.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h11, h6 the following sections were corrected: d10, h6.D10: (b)(6) 300-30-08 - equinoxe preserve stem 8mm (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) 320-20-00 - eq reverse torque defining screw kit (b)(6) 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm (b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm (b)(6) 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm (b)(6) 321-52-07 - 3.2mm drill bit sterile.No device was returned for evaluation; the reported event was confirmed by review of radiograph images provided.The review identified that based on the provided imaging it appears that the glenosphere is not seated fully on the glenoid baseplate.Based on the length of time the devices have been implanted, it is likely that the glenosphere locking screw was not fully seated during the time of implantation, resulting in the observed loosening of the glenosphere.Per the equinoxe shoulder primary reverse operative technique, optech-000160 rev a, when implanting the glenosphere, ¿run an instrument along the backside of the glenosphere to feel for the plate.You should not feel any of the plate if the glenosphere is seated properly.¿ images of the explanted devices were provided.There appears to be abrasive wear on the articular surface of the explanted humeral liner.This wear appears consistent with abnormal articulation between the humeral liner and edge of a misassembled glenosphere.However, this cannot be confirmed from the information provided.The humeral components appear unremarkable for explanted components.Additionally, there appears to be an unbroken torque defining screw.Based on the provided information, it does not appear that this torque screw had been implanted prior to this revision.Operative notes and/or medical records were not provided for review of usage/ technique.A review of manufacturing data was performed and no discrepancies were found.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 device-device loosening of the glenosphere/glenosphere locking screw from the glenoid baseplate.This may have been due to incomplete initial seating of the glenosphere locking screw at the time of implantation.The wear observed on the explanted humeral liner was likely due to abnormal articulation between the humeral liner and glenosphere secondary to the incomplete seating of the locking screw.However, the cause of the prosthesis wear cannot be confirmed and potential contributions of patient-related considerations to the event could not be assessed as the devices were not returned for evaluation.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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 23500958
• Report Number: 1038671-2025-03292
• Device Sequence Number: 21108696
• 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: 2023
• Device Explanted Year: 2024
• 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): 02/12/2026

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: 320-38-00
• 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: 02/27/2024
• Supplement Date Received by Manufacturer: 12/15/2025; 02/12/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/31/2025; 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2023
• 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; SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male