MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE REVERSE 42MM HUMERAL LINER +2.5

Catalog Number 320-42-03

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); No Information (3190)

Event Date 02/15/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2018.Revision due to dissociation.Patient was on vacation and moved his arm back and felt a pop 6 weeks post op.Upon x-ray, poly had disassociated from humeral tray.

Manufacturer Narrative

Section h10: (a1) patient identifier (in confidence):(b)(6).(a2) age at the time of event: 64 years.(b2) outcomes attributed to adverse event: added check for hospitalization - initial or prolonged.(d4) expiration date: 24-apr-2023, unique identifier (udi) #: (b)(4).(d6) if implanted, give date: (b)(6) 2018.(e3) occupation: physician.(g5) pma/510(k)number: k063569.(h3) the revision reported was likely the result of incomplete seating of the torque defining screw, the humeral liner, or a combination of the two at the time of implantation which may have contributed to disassociation of the humeral liner from the humeral adapter tray.(h4) device manufacture date: 26-apr-2018.(h6) evaluation codes: 1924, 2923.Section h11: the following sections have corrected information: (e2) health professional?: yes.(g3) report source: should of been health professional on first report.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE REVERSE 42MM HUMERAL LINER +2.5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8451159
• MDR Text Key: 139806722
• Report Number: 1038671-2019-00186
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2023
• Device Catalogue Number: 320-42-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Date Manufacturer Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 109