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 Codes	Granuloma (1876); Unspecified Infection (1930); Medical device site infection (4845)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6) 300-01-10 - equinoxe humeral stem primary press fit 10mm, (b)(6) 315-35-00 - glnd kwire, (b)(6) 320-06-42 - glenosphere 42mm, (b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0, (b)(6) 320-15-05 - eq rev locking screw, (b)(6) 320-15-08 - sup/post aug plate, r rs glenoid baseplate, (b)(6) 320-20-00 - eq reverse torque defining screw kit, (b)(6) 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm, (b)(6) 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm, (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, (b)(6) 321-20-00 - equinoxe reverse shoulder drill kit.
Event or Problem Description
It was reported that a 74 yo female patient, initial right shoulder implanted in (b)(6) 2021, underwent a revision procedure in (b)(6) 2024, approximately 3 years 5 months post the initial procedure.The patient's right shoulder was very tender and had a small area of granulation at the bottom of the womb, consistent with infection, possibly due to polyethene wear.All implants were removed due to infection.An antibiotic spacer was placed.The 42 +0 humeral liner that was implanted was affected by the recall, the poly did appear to have some wear, but is not certain that was the cause of the infection.The patient had a fall on the right shoulder in 2023, but it appeared fine.Cultures were sent and the pathology well be provided to the surgeon.There were no device breakages or surgical delays during the procedure.X-rays were provided.The explanted devices are available for return.Device images were provided.No further information.
Additional Manufacturer Narrative
The revision reported may have been due to infection as reported.An additional reason for the reported revision may have been prosthesis wear of the humeral liner.However, the reported infection could not be confirmed from the information provided.Additionally, potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and relevant clinical information were not provided.H6: corrected health effect and investigation clinical codes.

• 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 66 court; gainseville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 21034491
• Report Number: 1038671-2024-05046
• Device Sequence Number: 15754923
• Product Code: KWT
• UDI-Device Identifier: 10885862086693
• UDI-Public: 10885862086693
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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 Expiration Date: 04/18/2026
• Device Catalogue Number: 320-42-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2024
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2021
• 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: 74 YR
• Patient Sex: Female