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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034201903854.

Event Description

It was reported that when the customer opened the cobalt cement hv powder, part of the powder had already hardened.This surgery was finished with backup product.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).Two boxes were returned and evaluated both cobalt hv bn cmt 40g-(b)(6).Upon visual inspection box one was returned with the powder in a separate bag.Box one had a powder package with some hardened powder inside the opened pouch with the back side of the pouch also shows blue staining.Box two was returned with opened packaging for used materials.The returned powder package had a layer of hardened powder inside the opened pouch with the back side of the pouch also shows blue staining.Product evaluation does not change the previous investigation results.

Event Description

No further event information available at the time of this report.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of distributor communication.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• 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
• MDR Report Key: 8946592
• MDR Text Key: 158627117
• Report Number: 0001825034-2019-03853
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• PMA/PMN Number: K051532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 402282J
• Device Lot Number: 835900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 08/29/2019
• Supplement Dates Manufacturer Received: 11/20/2019; 02/20/2020
• Supplement Dates FDA Received: 11/21/2019; 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1