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

Catalog Number	320-42-00
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient was complaining of a sore shoulder.The surgeon was revising the glenoid due to some loosening.Patient's glenoid was revised to competitor's device.There was no breakage of a device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Photos and x-rays received.The device is not available for evaluation due to resident wanted to keep them.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10: (b)(6) - 300-30-06 - equinoxe preserve stem 6mm (b)(6) - 320-06-42 - glenosphere 42mm (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) - 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm (b)(6) - 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm (b)(6) - 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.The product associated with the reported event is within the scope of recall z-1422-2024; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The revision was most likely due to fracture of the compression screws from increased bending moments caused by baseplate loosening and/or an inadequate number of screws being used for fixation.Furthermore, the prothesis wear on the humeral liner from scapular notching and/or the inclusion of the polyethylene in the packaging recall could have contributed to the reason for revision.However, the cause for the wear and fracture can not be confirmed from the provided information.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 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
• MDR Report Key: 21739012
• Report Number: 1038671-2025-01696
• Device Sequence Number: 4046195
• Product Code: KWT
• UDI-Device Identifier: 10885862086693
• UDI-Public: 10885862086693
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/01/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/15/2025
• Device Catalogue Number: 320-42-00
• 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: 03/13/2024
• Initial Report FDA Received Date: 04/01/2025
• Date Device Manufactured: 12/22/2020
• 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; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male