MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; CAGE GLENOID M, POST AUG, LEFT

Model Number	314-13-23
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 310-01-44, equinoxe, humeral head short, 44mm (alpha).
Event or Problem Description
As reported, this (b)(6) patient experienced left aseptic glenoid loosening.Complete glenoid loosening migration of the pegs.The case report form indicates this event is possibly related to devices and not related to procedure.This patient has a history of osteoarthritis.This event report was received through clinical data collection activities.The device is returning for evaluation.
Additional Manufacturer Narrative
Section h10: h3: the revision reported was likely due to a ¿rocking horse effect¿ generating forces around the well-fixed center peg that ultimately fractured the center peg secondary to contributions from anatomic instability within the shoulder joint, misalignment of the inferior peripheral pegs of the caged glenoid at the time of implantation, and potentially a lack of cement on the peripheral pegs.However, the individual contributions of instability, misalignment of the peripheral pegs, and lack of cement on the peripheral pegs to the sequence of events cannot be determined.H6: health effect - impact code: 4629, device revision or replacement; component code: 912, post.

• Brand Name: EQUINOXE
• Common Device Name: CAGE GLENOID M, POST AUG, LEFT
• 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: 11306670
• Report Number: 1038671-2021-00029
• Device Sequence Number: 19124457
• Product Code: KWT
• UDI-Device Identifier: 10885862196170
• UDI-Public: 10885862196170
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2023

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: 02/16/2020
• Device Model Number: 314-13-23
• Device Catalogue Number: 314-13-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2015
• 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 H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 64 KG