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

Model Number N/A

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the cement at 23.5 degrees celsius was stored uncooled and was put at the beginning of the operation in the operating room about 45 minutes up to surgery.At the beginning of the operation, the cement had 19 degrees.The cement cured after 14.5 minutes, which is too long for the surgeon, did not take so long before.Operating room temperature 19.5 degrees celsius, humidity 15.7.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following section has been updated : b5, d5, e1, g1-2, g4, g5, h2, h3, h6, h10.The device was not returned to the manufacturer.Therefore it could not be analyzed.However, reserve sample from the same lot was tested under standardized conditions.The product did not show any unusual behavior during mixing, handling or setting.The reported behavior of the cement could not be confirmed.The review of the device manufacturing quality record indicates that (b)(4) products designation optipac 80 refobacin bone cement r-3, reference 4712500398-3, lot number 741ba07090 were manufactured on 05 february 2018.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the complaint issue.No other complaint on this issue has been recorded for optipac 80 refobacin bone cement r-3, reference 4712500398-3, lot number 741ba07090 within one year.With the available information, the exact root cause of the event could not be determined.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 the cement at 23.5 degrees celsius was stored uncooled and was put at the beginning of the operation in the operating room about 45 minutes up to surgery.At the beginning of the operation, the cement had 19 degrees.The cement cured after 14.5 minutes, which is too long for the surgeon, did not take so long before.The operating room temperature was 19.5 degrees celsius and humidity 15.7.There was no patient involvement.No adverse event have been reported, as result of the malfunction.

• Brand Name: OPTIPAC 80 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
• MDR Report Key: 8463838
• MDR Text Key: 140297011
• Report Number: 3006946279-2019-00185
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 04040029922385
• UDI-Public: (01)04040029922385
• 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: 08/21/2019

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: 07/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 4712500398-3
• Device Lot Number: 741BA07090
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 08/07/2019
• Supplement Dates FDA Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1