MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC 80 REFOBACIN BONE CEMENT R-3; BONE CEMENT, ANTIBIOTIC

Catalog Number 4712500398-3

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

Event Description

It was reported that two optipac 80 were mixed in succession, in both cases the cement was difficult to mix.After 4 minutes, the cement had already hardened and had to be discarded.This mixing issue has led to a delay of 40 min during the surgery.No adverse event has been reported for the patient.

Manufacturer Narrative

This is a combination product (b)(4).This follow-up report is being submitted to relay additional information.No further information provided (x-rays, surgical report, photographs, lab test).The product analysis can't be performed as the product was not returned.The review of the device manufacturing quality can't be performed as the product batch number was not communicated.A complaint extract was done regarding cement paste too short setting time: - 1 complaint (2 products), this one included, has been recorded on optipac 80 refobacin bone cement r-3, reference (b)(4), from january 01, 2017 to february 10, 2021.- the complaint history, regarding the batch number, can't be performed as it was not communicated.According to available data, root cause of the event was unable to be determined.However, there is no evidence that the event is related to the product.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that two optipac 80 were mixed in succession, in both cases the cement was difficult to mix.After 4 minutes, the cement had already hardened and had to be discarded.This mixing issue has led to a delay of 40 min during the surgery.No adverse event has been reported for the patient.

• Brand Name: OPTIPAC 80 REFOBACIN BONE CEMENT 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
• MDR Report Key: 10934456
• MDR Text Key: 219545620
• Report Number: 3006946279-2020-00231
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4712500398-3
• Device Lot Number: NOT COMMUNICATED
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 02/22/2021
• Supplement Dates FDA Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1