MAUDE Adverse Event Report: HERAEUS MEDICAL GMBH COPAL EXCHANGE G KNEE L; KNEE SPACER

Model Number 5034796

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/10/2024

Event Type  Injury  

Manufacturer Narrative

Currently only limited information about the event and the patient are available.Heraeus has send an additional questionnaire form to the hospital to receive further information.However until now the document was not received back.The review of quality records showed that the batch 97254991kl was prepared in accordance with the requirements of our quality management system and all quality control tests have been passed successfully.Based on the knowledge and information available to us, we cannot identify a product deficiency.The surgeon rushed to use copal® exchange g without proper preparation, so no trials were available in the operations room.Therefore, the required size was not measured with a trial and the spacer was applied directly.The ifu of copal exchange g advises: " before inserting copal® exchange g knee, the suitable size should be determined intraoperatively with the help of trials." thus, this event is assessed as user error with serious outcome.

Event Description

During 1st stage of 2 stage revision surgery, the surgeon had difficulties to create the femur spacer by using spacer molds.To finish the surgery, it was decided to use a pre-fabricated spacer instead.Due to this a-hoc decision, no spacer trials for measuring out the size were available in the theatre.The surgeon estimated that a size l spacer would fit and started implanting without being able to test the assumed size first.During the cementing step, it turned out that this size was too big and the spacer was explanted again.The surgeon took a size m spacer which fit well, and finished the surgery.

• Brand Name: COPAL EXCHANGE G KNEE L
• Type of Device: KNEE SPACER
• Manufacturer (Section D): HERAEUS MEDICAL GMBH; philipp-reis-strasse 8/13; wehrheim, hesse 61273 ; GM 61273
• Manufacturer (Section G): HERAEUS MEDICAL GMBH; philipp-reis-strasse 8/13; wehrheim, hesse 61273 ; GM 61273
• MDR Report Key: 18657118
• MDR Text Key: 334723735
• Report Number: 3006406161-2024-00206
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K191016N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2024

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?: No
• Device Model Number: 5034796
• Device Lot Number: 97254991KL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/03/2020
• 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): Other