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

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 09/28/2016

Event Type  malfunction  

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.The following sections could not be completed with the limited information provided: device info - expiration date ni.Manufacture date ¿ ni.Udi# (b)(4).

Event Description

During a hip arthroplasty, the cement took 20 minutes to harden rather than the usual 12 minutes.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.The dhr was reviewed and no discrepancies were found.A test was performed using an item of similar batch, and no unusual behavior was noted.Root cause was unable to be determined, as the necessary information to adequately investigate the reported event was not provided.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 contribute to monitor for trends.

• Brand Name: OPTIPAC 40 REFOBACIN REVISION
• 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: 6061764
• MDR Text Key: 58608215
• Report Number: 3006946279-2016-00405
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 4730501163-1
• Device Lot Number: A523B08720
• Other Device ID Number: SEE NARRATIVE IN H10
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1