MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 42MM HUM LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	322-42-00
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.D10: 300-01-11 - equinoxe, humeral stem primary, press fit 11mm, (b)(6).315-35-00 - glnd kwire, (b)(6).320-06-42 - glenosphere, 42mm (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).320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, (b)(6).320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, (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, (b)(6).322-10-05 - humeral adapter tray, +5 (b)(6).
Event or Problem Description
As reported, approximately 3 years post the previous left shoulder surgery, the patient presented to the surgeon's prior to surgery with a dislocated shoulder.In situ humeral liner was removed and the surgeon trialed with a thicker humeral liner trial.Upon determining that the thicker liner provided the stability desired, the surgeon implanted the thicker liner.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
This follow-up report is being submitted to relay additional information.The following sections were updated: h3, h6.H3: the cause of the patient¿s shoulder dislocation and subsequent revision reported cannot be conclusively determined; however, it may be due to soft tissue imbalance, patient anatomy, implant positioning, and/or implant selection.Dislocation is a known risk, as outlined in the ifu.

• Brand Name: 145-DEG PE 42MM 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: 21984699
• Report Number: 1038671-2025-02003
• Device Sequence Number: 11840351
• Product Code: KWT
• UDI-Device Identifier: 10885862593917
• UDI-Public: 10885862593917
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K223833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted 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,Followup
• Report Date (Section B): 07/30/2025

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 Catalogue Number: 322-42-00
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male