MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE ANATOMIC REPLICATOR PLATE

Catalog Number 300-10-15

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Disorder (2373); No Information (3190)

Event Date 11/27/2017

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2013.Revision due to instability.

Manufacturer Narrative

In a review of the labeling it is a known complication that a patient's age, weight, or activity level would cause the surgeon to expect early failure of the system.Postoperative rotator cuff tear is a known complication associated with total shoulder arthroplasty.Rotator cuff strains or tears are caused by overuse or acute injury.Rotator cuff tear arthropathy is shoulder arthritis with a large rotator cuff tear.Revisions or surgical interventions are a known complication found in joint replacements.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the shoulder revision surgery is most likely related to the patient's underlying conditions, including rotator cuff tear arthropathy.This device is used for treatment, not diagnosis.

Event Description

It was reported from the united kingdom that a patient had a rotator cuff arthropathy that required revision surgery.The patient had a hemiarthroplasty that had been implanted in november 2013.This device was removed, along with the original stem, as it was not deemed stable enough to leave in place, the new stem was cemented.The patient was stable when they left the or.The surgeons were "pleased" with the outcome of the revision, and the post-op x-rays.There is no indication that the devices malfunctioned.No additional information is provided.This is one of four products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00855, 1038671-2017-00856 and 1038671-2018-00857.

• Brand Name: EQUINOXE ANATOMIC REPLICATOR PLATE
• Type of Device: REPLICATOR PLATE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7104273
• MDR Text Key: 94387240
• Report Number: 1038671-2017-00854
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/05/2018
• Device Catalogue Number: 300-10-15
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR