MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL STEM PRIMARY, PRESS FIT 11MM

Model Number EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/17/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant devices: 300-20-02, 5415004, torque screw kit; 300-10-45, 5325753, 4.5mm replicator plate; 310-01-50, 5314334, humeral head short 50mm.

Event Description

It was reported that a ¿large built¿ 70 yo male patient¿s shoulder was revised due to loosened components noted on x-rays.Reportedly, the patient was waterskiing approximately 3 months after the initial surgery, which was noted as probable cause of loosening.The humeral head implant removed easily with cobb elevator.Remainder of humeral construct removed by hand.Cultures were taken.Glenoid component inspected and no loosening or wear noted.Humeral canal was re-reamed and broached to a size 12mm.It was then assembled with a 1.5 replicator plate and implanted with antibiotic cement.A size 50mm x 19mm short head was affixed and the wound was closed.No instability noted at closure of the wound.The patient left the or in stable condition.

Manufacturer Narrative

Serial number: (b)(6); expiration date: 11-aug-2027, initial reporter occupation: physician, pma/510(k)number: k042021, primary surgery: (b)(6) 2018.Loosening noted on x-ray around humeral component.Patient was waterskiing in august after surgery which was noted as probable cause of loosening.Upon review of the available information, there is no evidence that this is a device related problem and no allegation against the device.Implantation of a total joint could result pain, infection, or loosening of total joint hardware.The most likely cause of the reported event is the patient¿s condition and activities.Device manufacture date: 11-aug-2017.Corrections made in the following section(s): please disregard lot number provided, it was actually the serial number.Labeled for single use should be yes.

• Brand Name: EQUINOXE
• Type of Device: HUMERAL STEM PRIMARY, PRESS FIT 11MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8859907
• MDR Text Key: 153245080
• Report Number: 1038671-2019-00390
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862079312
• UDI-Public: 10885862079312
• 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: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• Device Catalogue Number: 300-01-11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR