MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC 60 REFOBACIN BONE CEM ENT R; BONE CEMENT, ANTIBIOTIC

Model Number N/A

Device Problem Device Expiration Issue (1216)

Patient Problem No Information (3190)

Event Date 02/24/2016

Event Type  malfunction  

Manufacturer Narrative

The user facility is outside of the united states.Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.

Event Description

It was reported that patient underwent a total hip arthroplasty on (b)(6) 2016.During the procedure, expired cement was used.There have been no reported adverse effects and no revision procedure has been reported to date.

• Brand Name: OPTIPAC 60 REFOBACIN BONE CEM ENT 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
• 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 26903 ; FR 26903 ; 0334757591
• MDR Report Key: 5518818
• MDR Text Key: 40938376
• Report Number: 3006946279-2016-00022
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: PK150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 4711500396
• Device Lot Number: A344BJ3103
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1