MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; 36MM HUMERAL LINER +0 UNCONSTRAINED

Catalog Number 320-36-00

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Fall (1848)

Event Date 06/06/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Primary surgery: (b)(6) 2018.Revision due to dislocation.Patient with a reverse shoulder fell and dislocated her shoulder.She was brought in for an open/vs closed reduction.The closed reduction did not satisfy the surgeon so she was opened and a liner was upsized from a 36mm +0 to a 36mm+2.5 constrained.The surgeon was satisfied and patient is expected to recover and have a good outcome.

Manufacturer Narrative

The revision reported was likely due to a post traumatic event.A review of the dhr and/or the sterilization records was not conducted because the event as described is a clinical event that does not appear to be related to the design, manufacturing, or reasonably foreseeable misuse of the device.A review of ifu for equinoxe shoulder components (700-096-060 rev m) was conducted.As part of postoperative care of a reverse total shoulder arthroplasty, the patient should be cautioned to monitor activities and protect the replaced joint from unreasonable stresses.Dislocation of the prosthesis or any of its components may require a surgical intervention or revision as listed in the device specific risks section of the ifu.

• Brand Name: EQUINOXE
• Type of Device: 36MM HUMERAL LINER +0 UNCONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8756325
• MDR Text Key: 149912972
• Report Number: 1038671-2019-00352
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086617
• UDI-Public: 10885862086617
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2023
• Device Catalogue Number: 320-36-00
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR