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

Catalog Number	600-15-100
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
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
Instrument failure - 30 minute delay in surgery.
Additional Manufacturer Narrative
The agent reported that (there has been a reported inconsistency of the cobalt hv bone cement irregularity in setting/working time of the cement.The rep was able to obtain the lots prior to the boxes being disposed.2 separate cases the cement did not bond to the implant causing early failure of the components.) this event occurred during surgery, near the patient.Serious risk to patient was reported by the surgeon.The surgery was completed as intended, with a thirty-minute delay.The cobalt cement was inspected prior to use and was deemed acceptable for use based on its appearance.The agent was present during surgery and was able to source a suitable replacement device.The cobalt cement packages were not returned to djo for further examination, it has been verified by the agent that the units have been discarded on site.

• Brand Name: COBALT G-HV BONE CEMENT 40GM
• Common Device Name: BONE CEMENT
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 17733795
• Report Number: 1644408-2023-01249
• Device Sequence Number: 6399657
• Product Code: LOD
• UDI-Device Identifier: 00190446138013
• UDI-Public: 00190446138013
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K051532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2024
• Device Catalogue Number: 600-15-100
• Device Lot Number: 246C1D0103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 600-15-000 LOT: 234D2D0076.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Male