MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COBALT G-HV BONE CEMENT 40G; PROSTHESIS, BONE CEMENT

Model Number N/A

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 05/11/2015

Event Type  malfunction  

Manufacturer Narrative

Other - sales representative.(b)(4).This report is being submitted late as it has been identified in remediation.Complaint sample was evaluated and the reported event was confirmed.Complaint sample was received with the tyvek pouch cut open within an outer bag.Bag contents were examined and a hair was visualized.It is impossible to determine where the hair could have entered the product during manufacturing or if it could have occurred during the procedure being performed within the surgery area at point of use.This appears to be a random occurrence; therefore, root cause was unable to be identified.All device history records were reviewed to include dhr, deviation history, associated processing parameters and all items appear to be adequate in content and there were no anomalies identified within any of these items.Review of complaint history of this product does not show any other complaints of this nature.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that during a total knee arthroplasty, there was a black hair in the sterile package once the cement was transferred to the sterile field.The cement was not used.No adverse events have been reported as a result of the malfunction.

• Brand Name: COBALT G-HV BONE CEMENT 40G
• Type of Device: PROSTHESIS, BONE CEMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6951258
• MDR Text Key: 90309519
• Report Number: 0001825034-2017-08686
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK051532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 402283
• Device Lot Number: 519960
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2015
• 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
• Patient Age: 65 YR