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

Model Number N/A

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2015

Event Type  malfunction  

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The records for all items were reviewed to include dhr, deviation history, and processing parameters with all items to be adequate in content and requirements.No anomalies were identified within any of these items.Review of complaint history of this product does not show any other complaints which match this issue.It is impossible to determine where the debris 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 with no trend identified.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.The possibility of this type of an occurrence is identified within pfmeca cobalt hv bone cement, rev 1, per section 4.1.5 foreign object introduced into powder.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.Zimmer biomet complaint number: (b)(4).

Event Description

It was reported that during a surgery on (b)(6) 2015, a foreign substance similar to lint was discovered in the polymer when the polymer was poured into the mixing bowl.Per the surgeon, there wasn't any gauze in the operating field.The foreign substance was removed from the polymer and the polymer was used to complete the procedure.The surgeon believes that the foreign substance might have already been in the polymer pouch.No additional patient consequences were reported.

• Brand Name: COBALT HV BN CMT 40G-JAPAN
• Type of Device: 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: 6937878
• MDR Text Key: 89775633
• Report Number: 0001825034-2017-08354
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• 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: 402282J
• Device Lot Number: 784970
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2015
• 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