MAUDE Adverse Event Report: EXACTECH, INC. 13X80MM DISTAL STEM MODULAR CEMENTED; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	13X80MM DISTAL STEM MODULAR CEMENTED
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Medical device site infection (4845); Septic loosening (4884)
Date of Event	02/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products cemex system fast genta 70g (cat# 13a2101 / serial# (b)(6).Distal fixation ring ha 29.5 (cat# 308-05-29 / serial# (b)(6).Large prox body +0 (cat# 308-10-05 / serial# (b)(6).Taper locking screw 0 (cat# 308-15-01 / serial# (b)(6).Equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00 / serial# (b)(6).Eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(6).Eq rev compress screw lck cap kit, 4.5 x 42mm (cat# 320-20-42 / serial# (b)(6).Equinoxe reverse 46mm humeral liner +0 (cat# 320-46-00 / serial# (b)(6).Equinoxe reverse shoulder drill kit (cat# 321-20-00 / serial# (b)(6).Sterile disposable containers (cat# asa0030 / serial# (b)(6).Cemex gento low viscosity 40g kit (cat# 1400-ag / serial# (b)(6).Interspace tapered wedge 46mm short (cat# spc0023 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the equinoxe shoulder study, approximately 1 year(s) and 3 month(s) post implantation of left a third revised tsa (previous revision reported on mfr# 1038671-2024-01824), the patient presented with aseptic humeral loosening.Patient had revision to a hrp and has never had relief of pain.A bone scan was obtained which was returned suspicious for loose prosthesis and non-specific focal infection.This outcome of the event was resolved two months later by standard reverse with humeral reconstruction stem revision of the left shoulder and s/p antibiotic spacer placement five months following with continued lift shoulder pain.Plan to revise back to rtsa w/hrp.Pain could be result of continued glenoid wear from the spacer.The clinical report indicates that the event is definitely related to the device(s) and unlikely related to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported may be the result of the humeral stem loosening and infection as reported.However, the loosening and infection can¿t be confirmed and any potential contributions from user or patient-related contributing factors to the event can¿t be evaluated as no radiograph, images, or clinical information was provided.The reason for the infection cannot be conclusively determined; however, it may be related to an underlying patient condition and/or the surgical procedure.A review of the sterile certificate for all explanted components was performed and the sterile lots were accepted to the requirements.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: 13X80MM DISTAL STEM MODULAR CEMENTED
• 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; gainesville FL 32653
• Manufacturer Contact: geoff gannon
• MDR Report Key: 19568878
• Report Number: 1038671-2024-02005
• Device Sequence Number: 20571465
• Product Code: KWT
• UDI-Device Identifier: 10885862267924
• UDI-Public: 10885862267924
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K143659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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: 06/30/2026
• Device Model Number: 13X80MM DISTAL STEM MODULAR CEMENTED
• Device Catalogue Number: 308-01-13
• Device Lot Number: UNKNOWN
• 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: 05/22/2024
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2016
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Race: White