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 Embolism/Embolus (4438)

Event Date 09/10/2021

Event Type  Injury  

Event Description

It was reported that: a patient was operated on (b)(6) 2021 for a right intermediate prosthesis.He had an intraoperative fat embolism, remained in intensive continuous care until (b)(6) 2021.The hospital decided not to use this product anymore.

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 the patient was operated on (b)(6) 2021 for a right intermediate prosthesis.The patient had an intraoperative fat embolism, and remained in intensive care unit/continuous care until 25 september 2021.The hospital decided not to use this product anymore.

Manufacturer Narrative

(b)(4).This follow-up is to relay additional information.The product analysis can't be performed as the product was not returned.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".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.3 complaints (3 products), this one included, have been recorded on refobacin bone cement 1x40-3, reference (b)(4) since ever.All 3 complaints were reported by the clinique d'occitanie.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.

• 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: 12766506
• MDR Text Key: 280452478
• Report Number: 3006946279-2021-00191
• 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
• Report Date: 12/15/2021

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: 05/31/2023
• Device Catalogue Number: 3003940001-3
• Device Lot Number: AZ26AA1301
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2020
• 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): Hospitalization