MAUDE Adverse Event Report: ENCORE MEDICAL L.P. COBALT CEMENT; COBALT HV BONE CEMENT 40GM

Model Number 600-15-000

Device Problems Contamination /Decontamination Problem (2895); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/05/2019

Event Type  Injury  

Event Description

Complaint - 3 boxes of the same lot number didn't open the correct way resulting in contamination.

Manufacturer Narrative

The reason for this complaint was to report 3 boxes of the same lot number not opening the correct way resulting in contamination.This event occurred at inspection, away from the patient, the agent was not present.There was no delay in surgery and no adverse event was reported and there was another suitable unit available.Manufacture of cobalt bone cement was recently transitioned from zimmer biomet to osartis.Shipments were received from osartis beginning (b)(6) 2018.Product was shipped to djo customers and consignment locations beginning (b)(6) 2018.Three customer complaints have been received in (b)(6) 2018 reporting problems with the new packaging.The outer pouch of the powder is designed to tear open at the top.When the customer tears the package, they may tear the inner sterile pouch resulting in a loss of the sterility of the cement copolymer powder.A review of the device history record (dhr) revealed no discrepancies or issues with the manufacturing history of this part.All parts conformed to design and manufacturing specifications at the time of manufacture.No non-conforming material reports were associated with this part.Due to multiple complaints being received in a short amount of time and the possibility of increased patient risk, health hazard evaluaiton, (b)(4), will be performed to assess patient risk related to this issue.Corrective and preventive action, capa ca-01482, has been opened to investigate root cause and determine corrective action.

• Brand Name: COBALT CEMENT
• Type of Device: COBALT HV BONE CEMENT 40GM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8381888
• MDR Text Key: 137530896
• Report Number: 1644408-2019-00144
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 00190446138006
• UDI-Public: (01)00190446138006
• Combination Product (y/n): N
• PMA/PMN Number: K051496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2020
• Device Model Number: 600-15-000
• Device Catalogue Number: 600-15-000
• Device Lot Number: 820D1D0008
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other