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

Model Number	600-15-100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reported incident - packaging complaint: a hospital contaminated the sterile field.The operating room director is demanding answers on why the packaging changed and when it will change back.They were very upset the morning that they opened up the new packages.Once they were in service on the new technique, they were okay.
Additional Manufacturer Narrative
The reason for this complaint was to report contamination of the sterile field.This incident occured in the opening room for an upcoming case, away from the patient.The representative was not present when the event occured, the component is not being returned.There was another suitable unit available and the surgery was completed as intended.Manufacture of cobalt bone cement was recently transitioned from zimmer biomet to osartis.Shipments were received from osartis beginning 13 jul 2018.Product was shipped to djo customers and consignment locations beginning 8 aug 2018.Three customer complaints have been received in september 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) could not be performed because the lot number was not reported.Due to multiple complaints being received in a short amount of time and the possibility of increased patient risk, health hazard evaluation hhe-2018-00010 will be performed to assess patient risk related to this issue.Correction and preventative action, capa ca-01482 has been opened to investigate root cause and determine corrective action.

• Brand Name: COBALT CEMENT
• Common Device Name: COBALT G-HV BONE CEMENT 40GM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8222224
• Report Number: 1644408-2019-00020
• Device Sequence Number: 2267003
• Product Code: LOD
• UDI-Device Identifier: 00190446138013
• UDI-Public: (01)00190446138013
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K051532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 600-15-100
• Device Catalogue Number: 600-15-100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2018
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other