MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC 40 BIOMET BC R; ORTHOPEDIC CEMENT, NON-ANTIMICROBIAL

Model Number N/A

Device Problem Chemical Problem (2893)

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

Event Date 10/18/2022

Event Type  malfunction  

Event Description

It was reported that during surgery, the cement hardened within 6-7 minutes.No health consequences or impact to patient were reported.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).Report source: foreign: japan.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

This follow-up report is being submitted to relay additional and/or corrected information.Product was not returned, or pictures not provided.Device evaluation could not be performed.A retained sample of the batch has been tested in the laboratory under standardized conditions.No unusual behaviour during mixing, handling or setting.The reported behaviour of the cement cannot be reproduced.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.This device is used for treatment.A definitive root cause cannot 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: OPTIPAC 40 BIOMET BC R
• Type of Device: ORTHOPEDIC CEMENT, NON-ANTIMICROBIAL
• 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: 15868493
• MDR Text Key: 304339808
• Report Number: 3006946279-2022-00112
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 04547038258042
• UDI-Public: (01)04547038258042(17)231130(10)AX14AB2114
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 110035374
• Device Lot Number: AX14AB2114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• Is the Device Single Use?: No
• 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 Sex: Prefer Not To Disclose