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

Catalog Number 600-15-100

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 08/15/2023

Event Type  malfunction  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

Instrument failure - 30 minute delay in surgery.

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
• Type of Device: 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
• MDR Text Key: 323258226
• Report Number: 1644408-2023-01249
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 00190446138013
• UDI-Public: 00190446138013
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 600-15-100
• Device Lot Number: 246C1D0103
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 09/12/2023
• Supplement Dates Manufacturer Received: 10/20/2023
• Supplement Dates FDA Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 600-15-000 LOT: 234D2D0076.
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Male