MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 1X40-3; ORTHOPAEDIC CEMENT, MEDICATED

Catalog Number 3003940001-3

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Arrest (1762)

Event Date 10/11/2021

Event Type  Injury  

Manufacturer Narrative

This is a combination product (b)(4).Report source, foreign, health professional - event occurred in (b)(6).The device manufacturing quality record indicate that the released product met all requirements to perform as intended.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: a patient was operated on (b)(6) 2021 for a left intermediate prosthesis.He had several intraoperative cardiac arrests, and went in the intensive care unit.Poor prognosis , the patient is in intensive care.

Event Description

It was reported that the patient was operated on (b)(6) 2021 for a left intermediate prosthesis.He had several intraoperative cardiac arrests, and is in the intensive care unit, with poor prognosis.

Manufacturer Narrative

This is a combination product (b)(4).This supplemental report is to relay additional information.The product analysis can't be performed as the product was not returned.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.No non conformity was found on the reference and batch number.1 other complaint on patient death following bone cement implantation syndrom was recorded on the batch since ever, and 2 other complaints on patient death following bone cement implantation syndrom was recorded from (b)(6) 2018 to (b)(6) 2021.Please note that all events occurred at the same hospital.The ifu of the product has been reviewed and it contains risk -reducing warning and different precautions regarding severe complications): "after preparation of the prosthesis bed or directly after the implantation of the cement and prosthesis, pressure rise in the medullary canal may cause a temporary fall in blood pressure.In addition to hypotension, pulmonary embolism and cardiac arrest, with their potentially fatal consequences, have been encountered in rare cases".According to available data, root cause of the event was unable to be determined.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 the patient was operated on (b)(6) 2021 for a left intermediate prosthesis.Had several intraoperative cardiac arrests.The patient is in intensive care with poor prognosis.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Product from the same batch number and retained by the hospital has been received for analysis.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.A sample returned from the hospital of same batch has been tested in the laboratory under standardized conditions.No unusual behavior during mixing, handling or setting.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.The review of the raw material certificate shows no non conformity or deviation.Medical records were reviewed and there was no information regarding patient health condition that was not previously known.A definitive root cause cannot be determined.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

No further event information available at the time of this report.

• Brand Name: REFOBACIN BONE CEMENT R 1X40-3
• Type of Device: ORTHOPAEDIC CEMENT, MEDICATED
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12766469
• MDR Text Key: 280455813
• Report Number: 3006946279-2021-00190
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N/A
• 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,Followup,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 3003940001-3
• Device Lot Number: Z20BAD1401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2021
• 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): Hospitalization