MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN PLUS BONE CEMENT 40; BONE CEMENT, ANTIBIOTIC

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 07/26/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).Multiple mdr's were submitted for this event.Please see reports: 3006946279 - 2017 - 00253.3006946279 - 2017 - 00254.3006946279 - 2017 - 00255.3006946279 - 2017 - 00256.(b)(4).Concomitant products: 3020830401, refobacin plus bone cement 40 , qty 4, lots: a642bj2508, a651cj1703, a644bj2507, a705ak0104 report source- foreign.The event occurred in (b)(6).The product within this report is a combination product.Reserve sample was evaluated under standardized conditions and no failure of the bone cement was found; the product functioned as intended.Investigation results concluded that the reported event was likely due to a known risk, known as implantation syndrome.This risk is addressed in the instructions for use (ifu) of this device.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that during a procedure, the patient experienced decrease in blood pressure as the prosthesis was cemented.The surgery was ended by closing the arthrotomy.The patient was transferred to the intensive care unit where a cardiac ultrasound showed evidence of a cement embolism.Despite the reanimation measures taken, the patient expired.No further information is available at this time.

Manufacturer Narrative

(b)(4).An investigation has been performed, consisting of a product analysis and a documentary review.The documentary review showed that products were manufactured according to the pre-defined specifications of biomet france.Product analysis on retained samples from the same batch showed no unusual behaviour during mixing, handling or setting.The most probable reason for death is the cement implantation syndrome.This risk is described in the ifu provided with the product.No non-conformity has been detected concerning the products.

• Brand Name: REFOBACIN PLUS BONE CEMENT 40
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: helene bataille ; plateau de lautagne bp75; valence cedex, IN 26903 ; FR 26903 ; 5745273773
• MDR Report Key: 7046630
• MDR Text Key: 92554789
• Report Number: 3006946279-2017-00253
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PK150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 3020830401
• Device Lot Number: A642BJ2508
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 91 YR