MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE REPLICATOR PLATE 4.5MM O/S

Catalog Number	300-10-45
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical device(s): torque defining screw kit (cat# 300-20-02 / sn# (b)(4)).Humeral head short 44mm (cat# 310-01-44 / sn# (b)(4)).
Event or Problem Description
It was reported that the patient was experiencing pain.The original total shoulder arthroplasty was performed on this female patient¿s right shoulder on (b)(6) 2010.The glenoid component had been previously removed, and the patient had a hemi shoulder left in, so the physician wanted to revise to an rsa.The physician exposed the humeral component, removed the humeral head and replicator plate and checked stability of stem.It was well fixed.He then proceeded to the glenoid where he took cultures, then implanted an 8 degree posterior baseplate.He fixated the baseplate with peripheral screws and trialed a 38mm glenosphere with a +0 tray and +0 liner for a 38mm glenosphere.Rom checked and determined those to be the correct sizes.The physician then implanted a 38mm glenosphere with a +0mm humeral tray and +0mm poly for a 38mm glenosphere.It was assembled in situ and stability was checked and deemed appropriate.The patient was stable at the end of the case and is expected to have a good outcome.There was no reported patient injury.
Additional Manufacturer Narrative
Section h10: (b2) added hospitalization - initial or prolonged check box.(g5) pma/510(k)number: k042021 (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design, manufacturing, or patient related issues.The cause of the revision due to pain is most likely is related to an underlying condition of the patient.(h4) 28-jan-2010.

• Brand Name: EQUINOXE
• Common Device Name: EQUINOXE REPLICATOR PLATE 4.5MM O/S
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8955171
• Report Number: 1038671-2019-00444
• Device Sequence Number: 2099990
• Product Code: KWT
• UDI-Device Identifier: 10885862079398
• UDI-Public: 10885862079398
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

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: 01/27/2020
• Device Catalogue Number: 300-10-45
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 10/28/2019
• 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