MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0

Catalog Number 320-10-00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ossification (1428)

Event Date 08/31/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Index surgery: (b)(6) 2018.Revision due to heterotopic ossification.The case report form indicates this event is definitely not related to devices and possibly related to procedure.

Manufacturer Narrative

The engineering evaluation noted that the revision reported was likely the result of heterotropic ossification.However, this cannot be confirmed as the devices were not available for evaluation and no further information was provided.

Manufacturer Narrative

D4: added serial number (b)(4).

Manufacturer Narrative

Section h10: (a1) patient identifier (in confidence): (b)(6).(b2) added check for hospitalization - initial or prolonged.(d4) expiration date: 08-may-2028, unique identifier (udi) #: (b)(4).(d5) operator of device: health_care_professional.(d6) if implanted, give date: (b)(6) 2018.(d7) if explanted, give date: (b)(6) 2018.(g5) pma/510(k)number: k063569.(h3) patient was revised on (b)(6) 2018.Only the tray, liner and glenosphere were replaced.(h4) device manufacture date: 09-may-2018.(h5) labeled for single use?: yes.Section h11: corrections made in the following section(s): (e1) initial reporter: dr.(b)(6).(e2) health professional?: yes.(e3) occupation: physician.(e4) initial reporter also sent report to fda?: no.(g1) mdr reporting contact: (b)(6).(g3) report source: health professional.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8310046
• MDR Text Key: 135155083
• Report Number: 1038671-2019-00049
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/22/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 320-10-00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2019
• Initial Date FDA Received: 02/06/2019
• Supplement Dates Manufacturer Received: 01/17/2019; 01/17/2019; 10/30/2019
• Supplement Dates FDA Received: 03/12/2019; 07/09/2019; 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 88