MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE GLENOSPHERE 46X21MM INSET; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-10-46
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	10/01/2022
Type of Reportable Event	Malfunction
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: 300-30-10 - equinoxe preserve stem 10mm: (b)(6).320-46-00 - 145-deg pe 46mm hum liner +0: (b)(6).320-10-00 - equinoxe reverse tray adapter plate tray +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 9 day(s) post-operative of a right rtsa, it was reported via clinical study that the patient experienced glenoid/coracoid fxs which loosened glenoid.Patient does not report injury, but glenoid component was found to have shifted at initial post-op appointment.The patient underwent a standard reverse with preserve stem revision with the reported removal of the humeral tray, humeral liner, glenosphere, and glenosphere locking screw components.Patient was left with resection arthroplasty to allow baseplate to heal, revision arthroplasty completed three months following.The outcome of this event is now considered resolved and the clinical report indicates that this event is possibly 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.

• Brand Name: EQUINOXE GLENOSPHERE 46X21MM INSET
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-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: 20778754
• Report Number: 1038671-2024-04510
• Device Sequence Number: 21069979
• Product Code: KWS
• UDI-Device Identifier: 10885862565846
• UDI-Public: 10885862565846
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 320-10-46
• 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: 11/11/2024
• Initial Report FDA Received Date: 11/26/2024
• Date Device Manufactured: 04/22/2022
• 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: 81 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Race: White