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

Catalog Number	300-01-07
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
Primary surgery: (b)(6) 2007.The patients cuff tore and needed to be converted to a reverse.
Additional 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
• Common Device Name: HUMERAL STEM PRIMARY, PRESS FIT 7MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8739206
• Report Number: 1038671-2019-00335
• Device Sequence Number: 16654169
• Product Code: KWT
• UDI-Device Identifier: 10885862079299
• UDI-Public: 10885862079299
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/02/2011
• Device Catalogue Number: 300-01-07
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 10/22/2019
• 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: Required Intervention
• Patient Age: 44 YR
• Patient Weight: 68