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

Model Number	600-15-000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Complaint - due to the physician was impacting the tibia component using the appropriate mallet the cement ignited.Not sure the cause of ignition.
Additional Manufacturer Narrative
Manufacturer narrative: the reason of this surgery was reported as ignition of the cement caused by sparks from metal-metal instrument contact during impaction.The event occurred during surgery, near the patient.The agent was present and inspected the product before use, deeming it acceptable based on its packaged appearance.The surgery was completed as intended, and without delay.No adverse event, patient risk, or negative outcome due to the incident were reported.The devices were disposed of at hospital and not made available to djo surgical for examination.The cement's ifu is attached to this complaint; it cautions against using electrocautery devices near cement application, to avoid risk of causing a fire.Stray sparks from impaction have the ability to ignite flammable cement material as well.A full review of the device history record (dhr) cannot be conducted, as the cement's production lot's work order is not available at this time.The cement was within its expiration date at the time of surgery.No complaints have been filed against any other parts from this lot.No other complaints have been filed that report a similar incident.A possible root cause of this complaint is ignition of the cement caused by sparks from metal-metal instrument contact during impaction.The "appropriate mallet" referenced by the agent in the description of the incident could have been the source of a spark while being hit against the impaction handle, igniting the site due to the presence of freshly-mixed cement, where the liquid component of the mixture is a highly combustible material.There are no indications of a product or process issue affecting implant safety or effectiveness.
Event or Problem Description
Primary surgery - the physician was impacting the tibia component using the appropriate mallet the cement ignited not sure of cause of ignition.

• Brand Name: COBALT BONE CEMENT
• Common Device Name: COBALT HV BONE CEMENT 40GM
• Manufacturer (Section D): ENCORE MEDICAL L. P.; 9800 metric blvd; austin, tx
• MDR Report Key: 10144593
• Report Number: 1644408-2020-00470
• Device Sequence Number: 14249273
• Product Code: LOD
• UDI-Device Identifier: 00190446138006
• UDI-Public: (01)00190446138006
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (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): 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/30/2020
• Device Model Number: 600-15-000
• Device Catalogue Number: 600-15-000
• Device Lot Number: 844D1D0020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 09/18/2020
• 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
• Patient Age: 77 YR