MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 40MM CONST HUM LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-40-10
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 1 year and 10 months post left total shoulder arthroplasty (tsa), the humeral reconstruction prosthesis (hrp) and reverse baseplate were removed due to infection.A g21 molded antibiotic spacer was implanted.It was further stated that there was poly/liner wear.It was unclear if the device "broke" due to infection or vice versa.Labs were to determine what was infected.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending investigation.Concomitants: 308-05-27 - distal fixation ring ha 27.5 (b)(6) 308-01-13 - 13x80mm distal stem modular cemented (b)(6) 308-09-00 - small prox body +0 (b)(6) 308-15-01 - taper locking screw 0 (b)(6) 321-52-09 - 3.2mm k-wire, trocar tip (b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm (b)(6) 320-31-40 - glenosphere, 40mm (b)(6) 320-10-05 - equinoxe reverse tray adapter plate tray +5 (b)(6) 320-35-01 - small glenoid plate (b)(6) 321-52-07 - 3.2mm drill bit sterile (b)(6) 320-20-00 - eq reverse torque defining screw kit (b)(6) 320-15-05 - eq rev locking screw (b)(6) tpa-13 - cement restrictor xs (extra small, sz 13) (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) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm (b)(6).
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3, h6.Mdr section codes updated/corrected: b, c, d.The reason for the revision reported was likely the result of infection.The wear of the humeral liner observed in the provided images was likely due to scapular notching and subsequent impingement which may be related to the orientation of the components due to the patient¿s anatomy and/or inferior migration of the humerus as a result of improper implantation or laxity in the shoulder joint.The reason for the reported infection cannot be conclusively determined from the information available.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 40MM CONST 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: 20496978
• Report Number: 1038671-2024-04057
• Device Sequence Number: 4096086
• Product Code: KWT
• UDI-Device Identifier: 10885862535054
• UDI-Public: 10885862535054
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2024
• Device Catalogue Number: 320-40-10
• 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: 10/16/2024
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 10/02/2025
• Date Device Manufactured: 01/24/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male