MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL HEAD TALL, 44MM (ALPHA); PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	310-02-44
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	05/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): 300-01-09 - equinoxe, humeral stem primary, press fit 9mm: 7231165; 300-10-15 - equinoxe replicator plate 1.5mm o/s: 6895496; 300-20-02 - equinox square torque define screw drive kit: 5558407; 319-01-32 - steinmann pin sterile 3.2mm x 178mm: a123659; 321-20-00 - equinoxe reverse shoulder drill kit: a181542; 620-00-02 - platelet rich plasma kit with spray tips: 323221; 620-12-02 - accelerate prp 60 ml & acd-a: a20220003; asa0030 - sterile disposable containers ab6695; tpa-18 - cement restrictor small ab8949; 13a2101 - cemex system fast genta 70g ab8333.
Event or Problem Description
Approximately 1 year(s), 6 month(s) and 27 day(s) post-operative of a revised right tsa, the patient presented with aseptic glenoid loosening.It was described as continued bone loss of the glenoid.The patient underwent a standard total revision surgery.The outcome of this event is still considered continuing.The clinical report indicates that this event is possibly related to the device(s) and definitely related to the procedure.

• Brand Name: EQUINOXE, HUMERAL HEAD TALL, 44MM (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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19704151
• Report Number: 1038671-2024-02330
• Device Sequence Number: 12760292
• Product Code: KWS
• UDI-Device Identifier: 10885862083937
• UDI-Public: 10885862083937
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2024

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 Catalogue Number: 310-02-44
• 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: 06/27/2024
• Initial Report FDA Received Date: 07/09/2024
• Date Device Manufactured: 06/01/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 109 KG