MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC 60 REFOB BONE CMT R-3; BONE CEMENT, ANTIBIOTIC

Model Number N/A

Device Problems Device Ingredient or Reagent Problem (2910); Improper Chemical Reaction (2952)

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

Event Date 02/01/2023

Event Type  malfunction  

Event Description

It was reported that the bone cement has long setting time, approximately 14-15 minutes after vacuum mixing.The cement has a longer sticky and dough phases and it feels very soft during application.No consequences or impact to the patient.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 ¿ sweden.Investigation of this incident is currently ongoing.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 and/or corrected information.The following sections were updated: b4, b5, d2, g1, g3, g6, h1, h2, h6, h10.Upon further assessment of the reported event, it was determined that medwatch report should not have been filed as there was no indication that the device caused or contributed to a serious injury.Given this information, this medwatch report will be voided.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

Upon further assessment of the reported event, it was determined that medwatch report should not have been filed as there was no indication that the device caused or contributed to a serious injury.Given this information, this medwatch report will be voided.

• Brand Name: OPTIPAC 60 REFOB BONE CMT R-3
• Type of Device: BONE CEMENT, ANTIBIOTIC
• 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: 16583493
• MDR Text Key: 312120181
• Report Number: 3006946279-2023-00034
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 04040029922361
• UDI-Public: (01)04040029922361(17)231130(10)AY30AC2103
• 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: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• 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: 4711500396-3
• Device Lot Number: AY30AC2103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/20/2022
• 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 Sex: Prefer Not To Disclose