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

Model Number N/A

Device Problems No Flow (2991); Temperature Problem (3022)

Patient Problem No Information (3190)

Event Date 10/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The product within this report is a combination product.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the powder inside the cartridge appeared hard.It could not be penetrated by the plunger easily and only with high force.If this is attempted and the monomer is sucked in completely, the cement takes 25 minutes to harden at room temperature.A delay of 60 minutes was reported.No further information has been reported.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.The following sections were updated: if follow-up, what type?, device evaluated by mfr, evaluation codes.Reserve sample from the same lot was evaluated and the reported event was confirmed.Testing was performed under standardized conditions and the sample tested showed the polymer powder was compact and the setting time was too long.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined at this time; further investigation has been initiated to address reported issue.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-S 80 REFOBACIN CEMENT
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7037090
• MDR Text Key: 92994400
• Report Number: 3006946279-2017-00246
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: PK150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 4732501165-1
• Device Lot Number: A705C05628
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2017
• Initial Date FDA Received: 11/16/2017
• Supplement Dates Manufacturer Received: 12/07/2017
• Supplement Dates FDA Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other