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 09/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The device was not returned to the manufacturer.Therefore it could not be analyzed.The review of the device manufacturing quality record indicates that (b)(4) products optipac 80 refob bone cmt r-3, reference 4712500398-3, lot number a845b04160 were manufactured on 15 november 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 event described in the complaint.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 during surgery hardening time of the cement was extended.The storage temperature and the room temperature were 20 degrees celsius and the hardening time of the cement was 15 minutes which is 5 minutes longer than the reference.The surgery was finished with the same device but there was a delay of 10 minutes.This event concerns two products.No adverse events have been reported as a result of the malfunction.

Event Description

It was reported that during surgery hardening time of the cement was extended.The storage temperature and the room temperature were 20 degrees celsius and the hardening time of the cement was 15 minutes which is 5 minutes longer than the reference.The surgery was finished with the same device but there was a delay of 10 minutes.This event concerns two products.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).G3 - report source, foreign - event occurred in gemany.The device was not returned to the manufacturer.Therefore it could not be analyzed.However, a retain sample of the same batch number has been tested in the laboratory under standardized conditions (22,3°c; rel.Humid >=40 %).It has been found that no unusual behavior during mixing, handling or setting.The reported behavior of the cement cannot be reproduced.The result of the test was conform.The review of the device manufacturing quality record indicates that (b)(4) products optipac 80 refob bone cmt r-3, reference 4712500398-3, lot number a845b04160 were manufactured on 15 november 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 event described in the complaint.Within one year, no similar complaints have been recorded for optipac 80 refobacin bone cement r-3, reference 4712500398-3, batch a845b04160 regarding a too long setting time.According to the available data, the exact root cause of the event cannot be determined.A summary of the investigation has been sent to the complainant.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, ANTIBIOTIC
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 9184930
• MDR Text Key: 199898542
• Report Number: 3006946279-2019-00417
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 04040029922385
• UDI-Public: (01)04040029922385
• Combination Product (y/n): N
• 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: 01/15/2020

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: 04/30/2020
• Device Catalogue Number: 4712500398-3
• Device Lot Number: A845B04160
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1