MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; GLENOID, PEGGED BETA, LARGE

Model Number	314-02-14
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 300-01-09, 5241291, equinoxe, humeral stem primary, press fit 9 mm, 300-10-15, 5573988, equinoxe replicator plate 1.5 mm o/s, 300-20-02, 5631616, equinox square torque define screw drive kit, 310-01-47, 5490361, equinoxe, humeral head short, 47 mm (beta).
Event or Problem Description
It was reported an original left total shoulder arthroplasty was performed on this male patient on (b)(6) 2018 at york hospital.Patient had a failed subscapularis, and surgeon discussed converting to a reverse for better function.Patient was converted and a new stem was cemented in place.Patient left or stable and the surgeon believed there would be a successful outcome.
Additional Manufacturer Narrative
Section h10: (h3) as reported, the left total shoulder arthroplasty was performed on this male patient on (b)(6) 2018.Patient had a failed subscapularis, and surgeon converted to a reverse for better function and a new stem was cemented in place.Patient left or stable and surgeon believed there would be a successful outcome.Explants will not be returned per hospital policy.In a review of the labeling and ifu 700-096-004 rev.N, it is a known complication that excessive activity and trauma affecting joint replacements have been associated with premature failure and may require a second surgical intervention or revision.All patients should be instructed on the limitations of the prosthesis, the patient should be cautioned to monitor activities and protect the replaced joint from unreasonable stresses and follow the written instructions of the physician with respect to follow-up care and treatment.Upon review, there is no indication that there is a device related problem, there is no allegation against the device.The most likely cause of the reported event is related to the underlying patient condition.Section h11: corrections made in the following section(s): (b5) as reported, the left total shoulder arthroplasty was performed on this male patient on (b)(6) 2018.Patient had a failed subscapularis, and surgeon converted to a reverse for better function and a new stem was cemented in place.Patient left or stable and surgeon believed there would be a successful outcome.Explants will not be returned per hospital policy.
Event or Problem Description
As reported, the left total shoulder arthroplasty was performed on this male patient on (b)(6) 2018.Patient had a failed subscapularis, and surgeon converted to a reverse for better function and a new stem was cemented in place.Patient left or stable and surgeon believed there would be a successful outcome.Explants will not be returned per hospital policy.

• Brand Name: EQUINOXE
• Common Device Name: GLENOID, PEGGED BETA, LARGE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9152293
• Report Number: 1038671-2019-00481
• Device Sequence Number: 2615103
• Product Code: KWT
• UDI-Device Identifier: 10885862084521
• UDI-Public: 10885862084521
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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: 03/04/2023
• Device Model Number: 314-02-14
• Device Catalogue Number: 314-02-14
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR