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

Model Number	300-10-45
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	08/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The revision reported was most likely secondary to natural disease progression and/or rotator cuff failure leading to the need for a reverse total shoulder arthroplasty.Concomitant medical device(s): 300-20-02, (b)(4), equinox square torque define screw drive kit; 310-02-41, (b)(4), equinoxe, humeral head tall, 41mm (alpha).
Event or Problem Description
As reported, approximately 2.5 years postop the initial tsa, this (b)(6) y/o female patient lost range of motion in her right shoulder due to hemi-shoulder implant riding high on the glenoid.Stem retained.Converted to small baseplate/36mm.No devices to be returned, remain implanted.Patient was last known to be in stable condition following the event.

• Brand Name: EQUINOXE
• Common Device Name: REPLICATOR PLATE 4.5MM O/S
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10430508
• Report Number: 1038671-2020-00500
• Device Sequence Number: 16932859
• Product Code: KWT
• UDI-Device Identifier: 10885862079398
• UDI-Public: 10885862079398
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/20/2020

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: 03/30/2022
• Device Model Number: 300-10-45
• Device Catalogue Number: 300-10-45
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/20/2020
• 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: 75 YR