MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN PLUS BONE CEM 40 -3 -3; BONE CEMENT

Model Number N/A

Device Problems Off-Label Use (1494); Use of Device Problem (1670)

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

Event Date 07/13/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).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.

Event Description

It was reported that patient has been implanted with cement approximately month and a half after expiry date.There is no indication of any patient harm at this moment.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Product remains implanted and pictures not provided.However, the information in the dhr confirmed the references of the involved product and the expiration date of the batch number.This device is used for treatment.Investigation results concluded that the reported event was due to user error (expiration date exceeded).A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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.

• Brand Name: REFOBACIN PLUS BONE CEM 40 -3 -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: 15207833
• MDR Text Key: 297683526
• Report Number: 3006946279-2022-00087
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 00887868358425
• UDI-Public: (01)00887868358425(17)220531(10)923BAA2503
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 3020830401-3
• Device Lot Number: 923BAA2503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2019
• 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