MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE 13X120MM DISTAL STEM MODULAR CEMENTED; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	308-02-13
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	01/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.(d10) concomitant devices: 320-40-00 - 145-deg pe 40mm hum liner +0: (b)(6).320-10-00 - equinoxe reverse tray adapter plate tray +0: (b)(6).320-35-08 - small superior/posterior augglenoid plate,right: (b)(6).308-05-27 - distal fixation ring ha 27.5: (b)(6).308-10-00 - med prox body +0: (b)(6).308-15-01 - taper locking screw 0: (b)(6).If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
Approximately 2 month(s) and 12 day(s) post-operative of a right rtsa, it was reported via clinical study that the patient experienced aseptic glenoid loosening.Patient noticed increased pain and decreased motion without reported inciting event.X-rays and ct scan confirm aseptic glenoid loosening.It was noted in the patients medical history, a further diagnosis of humeral stem loosening.There were also notations regarding previous events of extensive debridement; hemiarthroplasty (biological glenoid w/humeral resurfacing); revision of hemi to tsa w/poly glenoid; revision to rtsa w/allografting to glenoid; and removal of implants, abx spacer, and debridement prior to the onset of the loosening event.The patient underwent standard reverse with humeral reconstruction stem revision with the reported removal of the torque screw, humeral tray, humeral liner, glenosphere, glenosphere locking screw, glenoid base plate, and compression screw/locking cap.The patient was bone grafted on the glenoid side using iliac crest autograft and donor allograft.Glenosphere was not placed.Patient will have ct scan at 3 months to assess healing.If there is consolidation of the graft and the baseplate is solid, surgeon will go back and place a glenosphere and remove the upside-down liner and tray and place a new tray and liner.An update was reported that the patient was seen approximately 5 months after revision and stable x-rays, revision surgery still pending.The outcome of this event is now considered resolved and the clinical report indicates that this event is definitely not related to the device(s) and definitely related to the procedure.This was reported through clinical trial study data collection activities and no other information is available at this time.Reported concomitant device(s): 320-40-00 - 145-deg pe 40mm hum liner +0: (b)(6).320-10-00 - equinoxe reverse tray adapter plate tray +0: (b)(6).320-35-08 - small superior/posterior augglenoid plate,right: (b)(6).308-05-27 - distal fixation ring ha 27.5: (b)(6).308-10-00 - med prox body +0: (b)(6), 308-15-01 - taper locking screw 0: (b)(6).
Additional Manufacturer Narrative
Correction: please disregard this report as it was reported in error.Event was previously reported under report #1038671-2023-01117.

• Brand Name: EQUINOXE 13X120MM 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; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20777651
• Report Number: 1038671-2024-04495
• Device Sequence Number: 4387876
• Product Code: KWT
• UDI-Device Identifier: 10885862267986
• UDI-Public: 10885862267986
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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 Catalogue Number: 308-02-13
• 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: 04/25/2023
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2018
• 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: Hospitalization
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White