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

Catalog Number 4712500398-3

Device Problem Improper Chemical Reaction (2952)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 08/04/2020

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 the cement did not mix well.The paste was watery after mixing.No known adverse event has been reported for now.

Event Description

It was reported that the cement did not mix well.The paste was watery after mixing.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following section has been updated: b4, e1, e2, e3, g4, g7, h2, h3, h6 and h10.The following section has been corrected: b3, b5.Received pictures show the patient labels: the ref/batch combination of the product involved in the complaint can be confirmed.Also,pictures of the optipac show that the cement has been mixed, the plunger is up, the mixing rod broken and the nozzle assembled.The paste seems homogeneous, no alter consistency can be seen.However, the cement paste seems to be white (and not green) which could indicate that the mixing was not completed.Also, it can be observed some empty space in the cylinder, which means that the cement was not pressurized enough.Indeed, the plunger is not up enough.The product analysis can't be performed as the product was not returned.A retain sample of batch az05dk0806 has been tested in the laboratory under standardized conditions (23°c; rel.Humid >=40 %).No unusual behavior during mixing, handling or setting.The reported behavior of the cement cannot be reproduced.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.A complaint extract was done regarding cement paste consistency: 1 complaint (1 product, this one included, has been recorded on optipac 80 refobacin bone cement r-3, reference (b)(4), from (b)(6) 2017 to (b)(6) 2021.1 complaint (1 product), this one included, has been recorded on optipac 80 refobacin bone cement r-3, reference (b)(4), batch az05dk0806.According to available data, root cause of the event was unable to be determined.A summary of the investigation was sent to the complainant conveying zimmer biomet conclusions.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.

• Brand Name: OPTIPAC 80 REFOBACIN BONE CEMENT R-3
• Type of Device: BONE CEMENT, ANTIBIOTICS
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 10435794
• MDR Text Key: 205142632
• Report Number: 3006946279-2020-00154
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

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 Expiration Date: 07/31/2021
• Device Catalogue Number: 4712500398-3
• Device Lot Number: AZ05DK0806
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 02/02/2021
• Supplement Dates FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1