MAUDE Adverse Event Report: EXACTECH, INC EQUINOXE HUMORAL HEAD, TALL; HUMERAL HEAD

Catalog Number 310-02-53

Device Problems Device Damaged Prior to Use (2284); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/14/2017

Event Type  Injury  

Manufacturer Narrative

Per the ifu, implants should be stored in their original, sealed packaging in clean, dry conditions.Prior to use, inspect the packaging and labeling for seal integrity.If the device has been opened, damaged or adulterated in any way, it must not be used.In order to ensure sterility, please observe aseptic surgical procedures when removing the implant from its packaging.The most likely cause of this event is related to the handling/transportation of the product inside the loaner kit.Additionally, the patient sustained serious injury related to the decision of the physician to implant a device when there was a suspicion that the integrity of the device's sterility may have been compromised (use error).

Event Description

It was reported that a patient underwent hip replacement surgery.It was determined that a 53mm humeral head was required so the appropriate implant was located, shown to the surgeon, shown to the circulator and consequently opened upon approval of product & expiration.It was noted that the outer box appeared worn however, outside wrap was not compromised & the seal was intact.The inside container also looked normal.When the packaging was opened and the internal container was passed to the sterile field, the inside container, containing the implant, appeared broken.The surgeon visually inspected the container that was opened for any signs of a compromise.None were detected visually.It was then suggested that a water test be conducted to identify any visually undetectable issues.Initially no issues were noticed as water did not leak from the package.The surgeon decided that the product was still sterile and the humoral head was implanted.Following the implant, the circulator emptied the package of water and noted that some of the water had, in fact, leaked out of what must have been a tiny hole or crack in the packaging.At this time, the surgeon made the decision to remove the "questionable" implant and replace it with a new one.Once the humoral head was removed, the joint was irrigated extensively with antibiotic fluids and betadine solution.Following completion of the irrigation, a new humeral head was implanted and the surgical procedure was completed.As of (b)(6) 2017, no untoward reactions have been reported about the patient.

• Brand Name: EQUINOXE HUMORAL HEAD, TALL
• Type of Device: HUMERAL HEAD
• Manufacturer (Section D): EXACTECH, INC; 2320 nw 66th court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: graham cuthbertcuthbert ; gainewville, FL 32653 ; 3523771140
• MDR Report Key: 8141746
• MDR Text Key: 129604923
• Report Number: 1038671-2018-05000
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2022
• Device Catalogue Number: 310-02-53
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 12/07/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/27/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 51 YR