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

Catalog Number	314-13-04
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this 70 y/o female patient's left shoulder was revised.Routine revision to reverse shoulder.Explantation of cage glenoid component during routine conversion to reverse shoulder arthroplasty.Reported event is not related to breakage of device and did not lead to surgical delay/prolongation.Patient was last known to be in stable condition following the event.Device is returning.Unable to obtain device images or x-rays.No further information.
Additional Manufacturer Narrative
D10: concomitants: 3631417 300-01-11 - equinoxe, humeral stem primary, press fit 11mm.3193707 300-10-45 - equinoxe replicator plate 4.5mm o/s.3634748 300-20-02 - equinox square torque define screw drive kit.2859128 310-01-44 - equinoxe, humeral head short, 44mm (alpha).

• Brand Name: EQUINOXE CAGE GLENOID LARGE, ALPHA
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 19566568
• Report Number: 1038671-2024-01987
• Device Sequence Number: 15197141
• Product Code: KWS
• UDI-Device Identifier: 10885862172709
• UDI-Public: 10885862172709
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/19/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 314-13-04
• 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: 06/07/2024
• Initial Report FDA Received Date: 06/19/2024
• Date Device Manufactured: 10/02/2012
• 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: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 71 KG