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

Model Number N/A

Device Problem Physical Property Issue (3008)

Patient Problem No Information (3190)

Event Date 08/19/2016

Event Type  Injury  

Manufacturer Narrative

This user facility is outside of the united states.The necessary manufacturing history to review was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.

Event Description

During a procedure, the cement hardened too quickly, causing malposition of the femoral component.No further information is available.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

Manufacturer Narrative

This follow up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).An investigation has been performed, consisting on a documentary review and a product analysis.A test was performed using an item of similar batch in the laboratory under standardized conditions.The sample tested did not show any unusual behavior during mixing, application or setting.As stated in the package insert, the working time and the rate of polymerization are strongly dependent on ambient temperature and temperature of the components.The hardening time is shorter at high temperatures and longer at low temperatures.A conclusive root cause could not be determined with the available information.

• Brand Name: OPTIPAC-S REFOBACIN PLUS BONE 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: elisabeth plane ; plateau de lautagne bp75; valence cedex ; 0334757591
• MDR Report Key: 5957326
• MDR Text Key: 54992219
• Report Number: 3006946279-2016-00320
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2016

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: 02/28/2017
• Device Model Number: N/A
• Device Catalogue Number: 4722502117-1
• Device Lot Number: C521B03528
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2016
• Initial Date FDA Received: 09/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/14/2016; 02/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: =
• Patient Sequence Number: 1
• Patient Outcome(s): Other