MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; GLENOID, PEGGED ALPHA, LARGE

Model Number	314-02-04
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The revision reported was likely the result of a combination of patient-related conditions and an insufficient bond between the glenoid component and the bone, which resulted in aseptic (non-infected) glenoid loosening.The loosening may have led to an increase in cement and bone particles in the joint space and resulted in prosthesis wear.However, this cannot be confirmed as the explants were not available for evaluation.Concomitant medical device(s): 310-01-53, 51491020 - equinoxe, humeral head short, 53mm (beta); 300-50-45, 58399002 - 4.5mm short rep plate; 320-20-42, eq rev compress screw lck cap kit, 4.5 x 42mm.
Event or Problem Description
As reported, approximately 7 years postop the initial right tsa, this (b)(6) y/o male patient, 6ft tall, presented with aseptic glenoid loosening.Ae exact date unk-gradual increasing pain over several years (not seen since 2014).A ct scan in (b)(6) 2020 showed lucencies around glenoid component.The case report form indicates this event is unlikely related to devices or procedure.The surgeon stated, ¿the glenoid wore out and the implant failed¿.The patient was converted from an anatomic shoulder to a reverse shoulder.Patient was last known to be in stable condition following the event this event report was received through clinical data collection activities and rep who was in attendance for the procedure.Devices will not return due to hospital policy.

• Brand Name: EQUINOXE
• Common Device Name: GLENOID, PEGGED ALPHA, LARGE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11403824
• Report Number: 1038671-2021-00083
• Device Sequence Number: 3545203
• Product Code: KWT
• UDI-Device Identifier: 10885862084491
• UDI-Public: 10885862084491
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2021

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 Model Number: 314-02-04
• Device Catalogue Number: 314-02-04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68
• Patient Weight: 130