MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PEGGED GLENOID

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Code Available (3191)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr? pending evaluation.Concomitant medical device(s): equinoxe, humeral head tall, 53mm (beta) (cat # 310-02-53 / sn# (b)(4)); 4.5 replicator plate (cat# 300-10-45 / sn# (b)(4)); torque screw (cat# 300-11-00 / sn# (b)(4)).

Event Description

It was reported that the patient had a rotator cuff failure, so the anatomic implants were successfully converted to a reverse.The stem remains.Patient was stable leaving the or and there was no delay to surgery.

Event Description

As reported, the patient had rotator cuff failure, so the anatomic implants were successfully revised to a reverse.The stem remains.Patient was stable leaving the or and there was no delay to surgery.Hospital policy that explants may not leave.Could not find numbers for a serial or part number for the peg glenoid.No other information is available at this time.

Manufacturer Narrative

Section h10: (h3) as reported, the patient had rotator cuff failure, so the anatomic implants were successfully revised to a reverse.The stem remains.Patient was stable leaving the or and there was no delay to surgery.Hospital policy that explants may not leave.Could not find numbers for a serial or part number for the peg glenoid.No other information is available at this time.In a review of the labeling and ifu 700-096-004 rev.N, the patient should be cautioned to monitor activities and protect the replaced joint from unreasonable stresses, and follow the written instructions of the physician with respect to follow-up care and treatment.Upon review of the available information, there is no evidence that this is a device related problem and there is no allegation against the device.Implantation of a total joint could result pain, infection, dislocation, or loosening of total joint hardware.The most likely cause of the reported event is the patient conditions.Section h11: corrections made in the following section(s): (b5) as reported, the patient had rotator cuff failure, so the anatomic implants were successfully revised to a reverse.The stem remains.Patient was stable leaving the or and there was no delay to surgery.Hospital policy that explants may not leave.Could not find numbers for a serial or part number for the peg glenoid.No other information is available at this time.

• Brand Name: EQUINOXE
• Type of Device: PEGGED GLENOID
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9207388
• MDR Text Key: 162975322
• Report Number: 1038671-2019-00519
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention