MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 36MM HUM LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-36-00
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Joint Impingement (4834)
Date of Event	12/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: (b)(6) - 300-30-09 - equinoxe preserve stem 9mm.(b)(6) - 319-01-32 - steinmann pin sterile 3.2mm x 178mm.(b)(6) - 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6) - 320-15-05 - eq rev locking screw.(b)(6) - 320-20-00 - eq reverse torque defining screw kit.(b)(6) - 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(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) - 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6) 320-31-36 - glenosphere, 36mm.(b)(6) 320-35-01 - small glenoid plate.(b)(6) 320-36-00 - 36mm humeral liner +0 unconstrained.(b)(6) 321-52-07 - 3.2mm drill bit sterile.The reason for the revision reported cannot be conclusively determined; but may be related to scapular notching, prosthesis wear, and loosening of the glenosphere locking screw.However, loosening and prosthesis wear cannot be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed from the information provided as the devices were not returned for evaluation and product images were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported, a male patient, initial right reverse tsa implanted and then underwent a revision procedure approximately 4 years 3 months post the initial procedure.The patient presented to the surgeon¿s office with complaints of dissatisfaction with their reverse shoulder.Upon examination and imagining, the patient was scheduled for a revision reverse tsa.The surgeon noticed scapular notching on the imaging.During the revision surgery, the surgeon saw the notching on the poly implant.The surgeon found that the central glenosphere screw was loose and not properly securing the glenosphere to the baseplate.The glenosphere screw was removed and the glenosphere was removed.There was prominent metalosis behind the glenosphere implant and around the baseplate implant.The tissue around the baseplate was debrided, and the baseplate was checked for stability.The surgeon thinks the loose fit of the glenosphere around the baseplate without a taper mechanism potentially causes micromotion, then loosening of the screw due to micromotion causes metal on metal reaction within the joint.The joint was irrigated well.A new and larger size and lateralized glenosphere 40mm was implanted.Trialing was performed, and then a new thicker tray and liner were implanted.An x-ray was provided.There was a 5-15 minute surgical delay during the procedure to debride metalosis around the glenoid baseplate implant with no adverse event to the patient as a result.There were no device breakages during the procedure.The patient was last known to be in stable condition following the event.No device returns available as they were discarded by the facility.No device images were provided.No further information.

• Brand Name: 145-DEG PE 36MM 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 23574400
• Report Number: 1038671-2025-03342
• Device Sequence Number: 18622911
• Product Code: KWT
• UDI-Device Identifier: 10885862086617
• UDI-Public: 10885862086617
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K093275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2025

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 Expiration Date: 11/20/2023
• Device Catalogue Number: 320-36-00
• 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: 12/27/2023
• Initial Report FDA Received Date: 11/17/2025
• Date Device Manufactured: 11/27/2018
• Is the Device Labeled for Single Use? (Y/N): No
• 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; Required Intervention
• Patient Sex: Male