MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID LARGE, BETA; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-13-14
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.
Event or Problem Description
It was reported that this patient's shoulder had a broken cage glenoid, this was found when surgeon was performing an arthroscopy.Patient had been complaining of pain after anatomic total shoulder.Glenoid was removed from patient, revision surgeon set for later date.Glenoid has been retrieved and will be returned to exactech.
Additional Manufacturer Narrative
(h3) the primary root cause of the ball detent feature remains as ¿material¿ as identified in a capa revisions 2 and 3.Specifically, the previous revisions of the engineering drawings for the ergo and gps shoulder impactor handles referenced dimensions for the internal depth of the bore as well as a spherical radius to create the smaller diameter end opening for retention of the detent ball.Use of internal bore dimensions required an inspection method that may have contributed to damage and did not provide a method for dimensional inspection after assembly that may have resulted in non-conforming product being released to the field.However, as there have now been two failures of devices with the updated design specifications, the root cause statement for the ball detent failures in a capa is being updated to also include to document these complaints and note that the failure to fully inspect the feature leading to additional complaints.The design does not identify the ball protrusion after assembly as a critical feature and therefore, does not require inspection.Prior to the capa rev 3, exactech was not inspecting this feature at 100% and the supplier is currently not inspecting at all.*the following sections have corrected information: h6: type of investigation, investigation findings, investigation conclusions.
Additional Manufacturer Narrative
The following sections have corrected information: (d1) brand name, (d4) catalog number, (h3) the revision reported was likely the result of prosthesis fracture of the glenoid body and disassociation of the center cage from the polyethylene body due to eccentric loading and subsequent prosthesis wear and rocking-horse motion around a well-fixed center cage.The potential contributions of off-label implantation of the glenoid without cement on the peripheral pegs, off-axis drilling of the holes for the peripheral pegs, and/or patient-related issues cannot be confirmed from the information provided.(h6) health effect clinical code, type of investigation, investigation findings, investigation conclusions.

• Brand Name: EQUINOXE CAGE GLENOID LARGE, BETA
• 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17877886
• Report Number: 1038671-2023-02458
• Device Sequence Number: 7389455
• Product Code: KWT
• UDI-Device Identifier: 10885862585325
• UDI-Public: 10885862585325
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2024

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 Catalogue Number: 314-13-14
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 07/29/2024; 08/19/2024
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 08/23/2024; 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: UNK.
• Patient Sex: Unknown