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

Model Number N/A

Device Problems Improper Chemical Reaction (2952); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).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 curing time of the cement was longer than normal, causing maybe a not good implantation of the stem.

Manufacturer Narrative

(b)(4).This follow-up report is being filled to relay additional information.The following sections were updated:b5, g1-2, g3, g4, h2, h3, h6, h10.The device was not returned to the manufacturer.Therefore it was not possible to analyze it.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 reproduced.The review of the device manufacturing quality record indicates that (b)(4) products optipac-s 80 refobacin bone cement r, reference 4712500398-1, batch a726c05250 were manufactured on 3rd november 2017.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.Another complaint has been recorded for optipac-s 80 refobacin bone cement r, reference 4712500398-1, batch a726c05250 on the reported event within one year, from the same hospital.With the available information, the exact root cause of the event could not be determined.An investigation has been performed, consisting of a documentary review and a reserve sample analysis.The documentary review showed that product was manufactured according to the pre-defined specifications of biomet france.The reserve sample analysis did not show any unusual behavior during mixing, handling or setting.According to available data, the exact root cause can¿t 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 has been reported that in two surgeries the polymerization time of the cement was longer than normal, causing maybe a not good implantation of the stem.Another optipac was used.No adverse events have been reported as a result of the malfunction.

• Brand Name: OPTIPAC-S 80 REFOBACIN BONE CEMENT R
• 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: 8252805
• MDR Text Key: 133513838
• Report Number: 3006946279-2019-00030
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: K150850
• 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: 08/27/2019

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: 04/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 4712500398-1
• Device Lot Number: A726C05250
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2018
• Initial Date FDA Received: 01/16/2019
• Supplement Dates Manufacturer Received: 08/26/2019
• Supplement Dates FDA Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1