MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COBALT HV BN CMT 40G-JAPAN; BONE CEMENT

Model Number N/A

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet in (b)(4) manufactures a similar device in the united states under 510k number k150850.

Event Description

It was reported that during a procedure, that the liquid polymer was missing in the cement system package.Subsequently, another cement system was used to complete the procedure.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

This report is being filed to relay additional information.(b)(4).

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.Visual inspection of the returned product determined that the product has been opened and the only items contained within the packaging are the powder, the patient stickers, and the ifu.As the product was returned opened and the number of components issued to the order matches the quantity manufactured on the router, the reported event cannot be confirmed.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action(s) are required.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.

• Brand Name: COBALT HV BN CMT 40G-JAPAN
• Type of Device: BONE CEMENT
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6133198
• MDR Text Key: 61087066
• Report Number: 0001825034-2016-04903
• Device Sequence Number: 1
• Product Code: MBB
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 402282J
• Device Lot Number: 540390
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2015
• 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