MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC SOFTPAC REFOBACIN REVISION 40; BONE CEMENT, ANTIBIOTIC

Model Number N/A

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Information (3190)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source- foreign.The event occurred in (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.Product remains implanted.

Event Description

It was reported the cement hardening took 20 min instead of 12 minutes.No further information has been made available at this ttime.

Manufacturer Narrative

(b)(4).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.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 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.According to the available data, a non-conformity has been detected.Related to the issue, a field action was initiated, in order to recall all affected products, which is not affecting american products.To date no adverse health outcome has been reported.If any further information is found which would changer any conclusions or information, a supplemental will be filled accordingly.

• Brand Name: OPTIPAC SOFTPAC REFOBACIN REVISION 40
• 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: helene bataille ; plateau de lautagne bp75; valence cedex, IN 26903 ; 5745273773
• MDR Report Key: 7152598
• MDR Text Key: 96124348
• Report Number: 3006946279-2017-00302
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 4730501163-1
• Device Lot Number: A705B05130
• Other Device ID Number: (01)03599870110362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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