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

Model Number	314-02-02
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 310-02-44, (b)(4)- equinoxe, humeral head tall, 44mm (alpha).302-01-10, (b)(4)- equinoxe, humeral stem primary, cemented 10mm.300-20-02, (b)(4)- equinox square torque define screw drive kit.300-10-45, (b)(4)- equinoxe replicator plate 4.5mm o/s.
Event or Problem Description
As reported, approximately 10 yrs postop the initial r tsa for this female patient, the right shoulder all-poly glenoid had loosened.The reason for the loosening is unknown, surgeon did not suspect infection.Surgeon removed all components in a single stage revision, converting to a reverse using an extended cage and bone graft.Patient was last known to be in stable condition following the event.Devices to be returned for evaluation.
Additional Manufacturer Narrative
(h3) the revision reported in was likely the result of an insufficient bond between the implant and the bone, which led to aseptic (non-infected) loosening of the glenoid component.

• Brand Name: EQUINOXE
• Common Device Name: GLENOID, PEGGED ALPHA, SMALL
• 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: 11973898
• Report Number: 1038671-2021-00286
• Device Sequence Number: 4204805
• Product Code: KWT
• UDI-Device Identifier: 10885862084477
• UDI-Public: 10885862084477
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 01/26/2022

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: 04/19/2016
• Device Model Number: 314-02-02
• Device Catalogue Number: 314-02-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2011
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female