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

Model Number N/A

Device Problem Clumping in Device or Device Ingredient (1095)

Patient Problem No Patient Involvement (2645)

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source (b)(6).This product is not cleared for distribution in the u.S.However, this report is being submitted as a similar device is cleared for distribution under 510k number k150850.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a surgery, the polymer was found to be hardened upon opening the bag of bone cement, a different product was needed to complete the surgery.No adverse events were reported as a result of this malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Udi# (b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned product identified that some amount of the cement powder had hardened on the tyvek side of the pouch.There was a slight brown discoloration on the rear side of the tyvek around the hardened cement.There was no puncture or damage to the packaging.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.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

No additional event information to report at this time.

• Brand Name: COBALT HV BN CMT 40G-JAPAN
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8136870
• MDR Text Key: 129495650
• Report Number: 0001825034-2018-11090
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 402282J
• Device Lot Number: 483920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1