MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL STEM PRIMARY, PRESS FIT 7MM

Catalog Number 300-01-07

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Failure of Implant (1924)

Event Date 05/29/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Primary surgery: (b)(6) 2007.The patients cuff tore and needed to be converted to a reverse.

Manufacturer Narrative

Section h10: (e3) occupation: physician.(g5) pma/510(k)number: k042021.(h3) the revision reported was likely the result of a dislocation.A review of the dhr and/or the sterilization records was not conducted because the event as described does not appear to be related to the design, manufacturing, or reasonably foreseeable misuse of the device.The ifu for equinoxe (700-096-060 rev m) was reviewed.Device specific risks include, but are not limited to fracture, migration, loosening, subluxation, or dislocation of the prosthesis or any of its components, any of which may require a second surgical intervention or revision.(h4) device manufacture date: 04-jan-2006.Section h11: corrections made in the following section(s): (g4) initial awareness date in initial submission should have been 29-may-2019.

• Brand Name: EQUINOXE
• Type of Device: HUMERAL STEM PRIMARY, PRESS FIT 7MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8739206
• MDR Text Key: 149345059
• Report Number: 1038671-2019-00335
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862079299
• UDI-Public: 10885862079299
• Combination Product (y/n): N
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2011
• Device Catalogue Number: 300-01-07
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 68