MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 2X40-3

Model Number N/A

Device Problem Improper Chemical Reaction (2952)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/12/2023

Event Type  Injury  

Event Description

It was reported that when the stem was being inserted into the femoral canal, it could not be fully seated due to the cement hardening faster than anticipated.As a result, the surgeon had to remove the stem, but some cement remained in place.A smaller-sized stem was then cemented into the existing cement mantle.During the procedure a small fracture occurred in the femur.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).G2 - foreign: sweden.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Product was not returned or pictures not provided.Visual device evaluation could not be performed.A retain sample of the same batch has been tested in the laboratory under standardized conditions.No unusual behavior during mixing, handling or setting.The reported behavior of the cement cannot be reproduced.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.This device is used for treatment.Medical records were not provided.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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 2X40-3
• Type of Device: BONE CEMENT
• 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: 17885017
• MDR Text Key: 325071093
• Report Number: 3006946279-2023-00083
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 00887868358395
• UDI-Public: (01)00887868358395(17)260131(10)AW07BC0608
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3003940002-3
• Device Lot Number: AW07BC0608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2023
• 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): Other
• Patient Sex: Female
• Patient Weight: 68 KG