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

Catalog Number	320-38-13
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Inadequate Osseointegration (2646)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 70 yo female patient, initial left shoulder implanted in (b)(6) 2024, underwent a revision procedure in (b)(6) 2025.The patient presented with a dislocation.The surgeon decided to change the humeral liner.When changing the liner, it was noticed the stem had come lose.The surgeon changed the stem, adapter tray and liner.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.No x-rays were able to be obtained.The explanted devices are not available for return.They were disposed of by the customer.No device images were able to be obtained.No further information.
Additional Manufacturer Narrative
D10: concomitants: 321-52-07 - 3.2mm drill bit sterile.320-38-03 - equinoxe reverse 38mm humeral liner +2.5.320-20-00 - eq reverse torque defining screw kit.300-01-11 - equinoxe, humeral stem primary, press fit 11mm.320-15-01 - eq rev glenoid plate.320-01-38 - equinoxe reverse 38mm glenosphere.320-15-05 - eq rev locking screw.320-10-00 - equinoxe reverse tray adapter plate tray +0.320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.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 reported shoulder dislocation, humeral loosening and subsequent revision reported cannot be confirmed as the devices were not returned for evaluation and possible contributions from user or patient-related conditions to the loosening cannot be determined due to limited clinical information.Contributing factors to the dislocation may be due to soft tissue imbalance, patient anatomy, implant positioning, and/or implant selection.Additionally, patient has a history of previous dislocation.Dislocation is a known risk, as outlined in the ifu.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 CONST 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, INC.; 2320 nw 66 court; gainseville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 21526262
• Report Number: 1038671-2025-01421
• Device Sequence Number: 9565190
• Product Code: KWT
• UDI-Device Identifier: 10885862086686
• UDI-Public: 10885862086686
• 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: 2024
• 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
• Report Date (Section B): 05/27/2025

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 Catalogue Number: 320-38-13
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2022
• 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: 70 YR
• Patient Sex: Female