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

Catalog Number	322-38-03
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: b284179 300-01-13 - equinoxe, humeral stem primary, press fit 13mm.(b)(6), 320-06-38 - glenosphere 38mm, (b)(6), 320-15-04 - rs glenoid plate r post aug, 8 deg, right, (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), 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, (b)(6), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, (b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, (b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, (b)(6), 321-52-07 - 3.2mm drill bit sterile, (b)(6), 322-10-00 - humeral adapter tray, +0, (b)(6), 322-38-00 - 145-deg pe 38mm hum liner +0.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a 60 yo male patient, who had a reverse shoulder revision prior, underwent another reverse revision.The patient complained of pain.Surgeon determined it was instability of the poly.A poly swap was done.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays were provided.The explanted devices are not available for return due to chain of command.No device images were provided.This is 1 of 2 cases for this patient.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, h6.Mdr section codes updated/corrected: b, c, d.The reason for the clinical symptom of pain reported cannot be conclusively determined and the event cannot be confirmed because the devices were not available for evaluation, and relevant patient information, images, or radiographs were not provided.An additional contributing factor to the revision may have been inclusion of the polyethylene in the packaging recall.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, SEMI-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; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 22723489
• Report Number: 1038671-2025-02688
• Device Sequence Number: 13003767
• Product Code: KWS
• UDI-Device Identifier: 10885862593849
• UDI-Public: 10885862593849
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 08/21/2025

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: 322-38-03
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2025
• 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: 60 YR
• Patient Sex: Male