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	03/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint - due to the outer packaging tearing and contaminating the sterile package.
Additional Manufacturer Narrative
The reason for this complaint was to report contamination of the sterile package.This event occurred during room preparation, away from the patient while the agent was present.There was no delay in surgery and no adverse event was reported.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 (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) 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) (b)(4) will be performed to assess patient risk related to this issue.Corrective and preventive action (capa) capa ca-01482 has been opened to investigate root cause and determine corrective action.Capa ca-01482 will assess root cause.(b)(4) will be completed to determine any required containment actions.

• 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: 8482735
• Report Number: 1644408-2019-00278
• Device Sequence Number: 1921714
• Product Code: LOD
• UDI-Device Identifier: 00190446138013
• UDI-Public: (01)00190446138013
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K051532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2019

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
• 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: 03/05/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 06/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 600-15-100; 600-15-100; 600-15-100; 600-15-100; 600-15-100; 600-15-100