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).Concomitant products: cobalt hv bn cmt 40g-japan, pn 402282j, ln 359570.(b)(6).Multiple mdr reports were filed for this event.Please see reports: 0001825034-2018-09960.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that dirt was found attached to the sterilization packaging.It is unknown if the dirt was on the outside or the inside of the package.Attempts have been made and additional information on the reported event is unavailable at this time.No further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon evaluation of the returned device, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.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 further event information available at the time of this report.

• 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: 8016802
• MDR Text Key: 125610853
• Report Number: 0001825034-2018-09961
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/30/2019

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: 03/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 402282J
• Device Lot Number: 233730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 10/29/2018
• Supplement Dates Manufacturer Received: 04/23/2019
• Supplement Dates FDA Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1