MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; SUP/POST AUG PLATE, R RS GLENOID BASEPLATE

Catalog Number 320-15-08

Device Problems Loose or Intermittent Connection (1371); Loosening of Implant Not Related to Bone-Ingrowth (4002)

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

Event Type  Injury  

Manufacturer Narrative

This event report was received through clinical data collection activities.Pending evaluation.

Event Description

Index surgery: (b)(6) 2016.Aseptic glenoid loosening.The case report form indicates this event is possibly related to devices and possibly related to procedure.

Manufacturer Narrative

Section h10: (a1) patient identifier (in confidence): (b)(6).(b2) outcomes attributed to adverse event: added check for hospitalization - initial or prolonged.(d4) catalog number: 320-15-08, serial number: (b)(6), expiration date: 20-sep-2026, unique identifier (udi) #: (b)(4).(e3) occupation: physician.(g5) pma/510(k)number: k131575.(h4) device manufacture date: 20-sep-2016.(h7) evaluation codes: 1924, 4002.Section h11: *the following sections have corrected information: (d1) brand name: equinoxe.(d2) common device name: sup/post aug plate, r rs glenoid baseplate.(e1) initial reporter name: dr.(b)(6).(e2) health professional?: yes.(g1) mdr reporting contact name: (b)(4).(g3) report source: health professional.(h3) the glenoid baseplate loosening reported was likely the result of the screw(s) fracturing.The underlying cause of the screw fracture is unknown but may have been the result of the reported patient fall.However, this cannot be confirmed as the devices have not been revised and, therefore, are not available for evaluation, and no further information was provided.*no information provided in the following section(s): b6, b7, d7, g8, h7, h9.

• Brand Name: EQUINOXE
• Type of Device: SUP/POST AUG PLATE, R RS GLENOID BASEPLATE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8304751
• MDR Text Key: 134993157
• Report Number: 1038671-2019-00046
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K131575
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 320-15-08
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2019
• Initial Date FDA Received: 02/05/2019
• Supplement Dates Manufacturer Received: 02/26/2020
• Supplement Dates FDA Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 144