MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC-S 60 REFOBACINE BONE CEMENT R; BONE CEMENT, ANTIBIOTIC

Model Number N/A

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2019

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 setting time was too long (18 minutes).

Event Description

It has been reported that the cement setting time was too long (18 minutes).No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being filled to relay additional information.The device was not returned to the manufacturer.Therefore it could not be analyzed.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 60 refobacin bone cement r, reference (b)(4), batch a726e02325 were manufactured on 7 september 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 event described in the complaint.No other complaint has been recorded for optipac-s 80 refobacin bone cement r, reference (b)(4), batch a726e02325 on the reported event within one year.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.

• Brand Name: OPTIPAC-S 60 REFOBACINE 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: 8437168
• MDR Text Key: 139347854
• Report Number: 3006946279-2019-00180
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 03599870112229
• UDI-Public: (01)03599870112229
• 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: 02/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 4711500396-1
• Device Lot Number: A726E02325
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 08/26/2019
• Supplement Dates FDA Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1