MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BC R 1X40 US; BONE CEMENT

Catalog Number 110034355

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2023

Event Type  malfunction  

Event Description

It was reported that the cement began to lose plasticity earlier than expected time.This event is related to a malfunction that could potentially lead to serious injury.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).D10: concomitant medical product: part#42-5026-066-02 lot#65873156 itemname#psn fem cr cmt cocr std sz9 r.Part#42-5320-075-02 lot#66021872 itemname#psn tib stm 5 deg sz f r.Part#42-5570-001-14 lot#66191407 itemname#psn straight hyb st 14 x +30 m.Part#42-5221-008-10 lot#65993376 itemname#psn mc ve asf r 1 0mm 8-11 ef.Part#00-5970-000-67 lot#zb23ebico1 itemname#psi psn pref cr pin goe set.Part#110034355 lot#ax48ca0604 itemname#refobacin bone cement r 1x40 us.Part#42-5402-000-35 lot#66030393 itemname#all poly pat ve 35 mm dia.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

No product was returned or pictures provided; visual evaluation could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Reported event did occur in an operating room or as part of a medical procedure, but review of the medical records has not been performed, as the event is not related to the medical procedure.With the available information, a definitive root cause could not be determined.It is not excluded that the mixing time (20 s instead of 30 s) had an impact on the cement setting time, however, surgeon had the same issue when mixing the cement 30 s.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 BC R 1X40 US
• 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: 18181381
• MDR Text Key: 328629632
• Report Number: 3006946279-2023-00098
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 00880304990197
• UDI-Public: (01)00880304990197(17)260430(10)W18BAB0603
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110034355
• Device Lot Number: W18BAB0603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2023
• 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 Sex: Prefer Not To Disclose