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

Catalog Number	320-38-03
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Fall (1848); Joint Dislocation (2374)
Date of Event	02/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 6 years and 11 months post the initial right total shoulder arthroplasty, the patient fell and dislocated their shoulder.They were unable to relocate in the emergency department, so open reduction was performed.The surgeon changed the poly liner as it had been in for 7 years.Photos provided show wear.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 concomitants: (b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(6) 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6) 320-15-05 - eq rev locking screw.(b)(6) 320-15-04 - rs glenoid plate post aug 8 deg, right.(b)(6) 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.(b)(6) 300-01-17 - equinoxe humeral stem primary press fit 17mm.(b)(6) 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.(b)(6) 315-35-00 - glnd kwire.(b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6) 320-01-38 - equinoxe reverse 38mm glenosphere.(b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(6) 320-20-00 - eq reverse torque defining screw kit.H3: the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: h6 the revision was likely due to shoulder dislocation secondary to a fall.A secondary finding is damage to the inferior lip of the liner, likely due to unintended contact with the scapular bone, but it does not appear to have been a contributing factor to the revision.However, the dislocation and any other contributing factors cannot be confirmed as radiographs were not provided 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.

• Brand Name: 145-DEG PE 38MM 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21572718
• Report Number: 1038671-2025-01539
• Device Sequence Number: 8272747
• Product Code: KWT
• UDI-Device Identifier: 10885862086662
• UDI-Public: 10885862086662
• 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: 2018
• 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): 05/01/2025

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: 05/23/2021
• Device Catalogue Number: 320-38-03
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 03/30/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2016
• 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: Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female