MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 38MM HUM LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-38-00
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately two years post initial right total shoulder arthroplasty, the male patient had a revision of their reverse shoulder due to infection.After exposing the joint, the implants were well fixed, however the joint was obviously infected.The glenoid baseplate was removed easily enough with a slap hammer without significant bone loss, and the stem was removed with osteotomes.An antibiotic cement spacer was implanted.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
H3: the reason for the reported revision due to infection cannot be conclusively determined; however, it may be related to an underlying patient condition.The prosthesis wear from impingement noted in the provided image does not appear to be related to the reason for the revision but may be related to implant positioning, implant size, and/or patient anatomy.However, this cannot be confirmed because the components were not returned for evaluation and no radiographs were provided.D10: (b)(6), 315-35-00 - glnd kwire, (b)(6), 320-01-38 - equinoxe reverse 38mm glenosphere, (b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0, (b)(6), 320-15-02 - rs glenoid plate sup aug, 10 deg, (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), 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, (b)(6), 531-20-00 - shldr gps rvrs drill kit, (b)(6), 531-78-20 - shouldr gps hex pins kit, (b)(6), a10012 - gps implant kit v2.

• Brand Name: 145-DEG PE 38MM 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 ; 3523771140
• MDR Report Key: 22125922
• Report Number: 1038671-2025-02217
• Device Sequence Number: 20709300
• Product Code: KWT
• UDI-Device Identifier: 10885862086655
• UDI-Public: 10885862086655
• 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: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2025

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: 09/23/2025
• Device Catalogue Number: 320-38-00
• 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: 06/02/2023
• Initial Report FDA Received Date: 06/02/2025
• Date Device Manufactured: 10/03/2020
• 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
• Patient Sex: Male