MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIVAC TOTAL HIP KIT; CEMENT MIXING KIT

Model Number N/A

Device Problem Incorrect Device Or Component Shipped (2962)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2014

Event Type  Injury  

Event Description

It was reported during a hip spacer mold procedure on (b)(6) 2014 when the cement was being mixed, it was noticed that two small plungers were included in the packaging instead of one small plunger and one larger plunger.Another package was opened and another long plunger was used to complete mixing the cement.There was a delay of approximately 45 minutes.

Manufacturer Narrative

No medwatch report was received.No product has been returned.Current information is insufficient to permit a conclusion as to the cause of the event.No further complications have been reported.Manufacture date - unknown.

• Brand Name: OPTIVAC TOTAL HIP KIT
• Type of Device: CEMENT MIXING KIT
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 2690 3; FR 26903
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 2690 3; FR 26903
• Manufacturer Contact: christophe mironneau ; plateau de lautagne bp75; valence cedex 26903 ; FR 26903 ; 0334757591
• MDR Report Key: 4248427
• MDR Text Key: 20751285
• Report Number: 3006946279-2014-00001
• Device Sequence Number: 1
• Product Code: JDZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 418000
• Device Lot Number: 0000937476
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2014
• 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
• Patient Outcome(s): Required Intervention