MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID L, POST AUG, LEFT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-13-24
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the equinoxe shoulder study, the patient had an initial left tsa on (b)(6) 2017 and presented on 12-nov-2019 with aseptic glenoid loosening.Glenoid loosening and humeral bone loss.The case report form indicates that this event is possibly related to device and definitely related to procedure.Outcome is resolved by revision on 18-dec-2019.Spacer - huge bone loss.No device return anticipated due to being a clinical trial study.Ebi initial surgery attached.
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): 300-30-06 - equinoxe preserve stem 6mm: 4963983 310-01-50 - equinoxe, humeral head short, 50mm (beta): 5044142 300-10-45 - equinoxe replicator plate 4.5mm o/s: 5082308.

• Brand Name: EQUINOXE CAGE GLENOID L, POST AUG, LEFT
• 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 66th ct.; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18465133
• Report Number: 1038671-2024-00031
• Device Sequence Number: 7154860
• Product Code: KWS
• UDI-Device Identifier: 10885862200983
• UDI-Public: 10885862200983
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/08/2024

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: 03/08/2022
• Device Catalogue Number: 314-13-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2017
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 215 LB
• Patient Race: White