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

Model Number	600-15-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	06/26/2023
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
Revision surgery: due to pain.
Additional Manufacturer Narrative
The reason for this revision surgery, the agent reported "((right knee (b)(4)) it was reported a patient underwent a right knee arthroplasty on an unknown date.Subsequently patient is experiencing chronic pain, swelling & potential nickel allergy.Allergic reaction.Male, 74)." the cement was lost/discarded, therefore the item could not be examined.This event occurred post operative near the patient.The components were not inspected prior to surgery.There was not another suitable device available, however, the incident did not cause a delay in surgery.There was no risk or adverse event reported and the surgery was completed as intended.Surgical components condition can be determined while being used for its intended purpose.This does not indicate a product deficiency, failure, or issue.No further action is deemed necessary at this time.A review of the receipt shows that the reported item, when released for use, met all certificate requirements.There were no nonconforming material reports associated with the item that may have contributed to the reported event.Customer complaint history showed that this is the first complaint against 600-15-100 lot# 950c1d0043 across all failure code categories.The root cause for this complaint is that the patient is experiencing chronic pain, swelling & potential nickel allergy.There are multiple factors that may contribute to an event which are outside of the control of djo surgical.

• 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: 17368477
• Report Number: 1644408-2023-00951
• Device Sequence Number: 17928561
• Product Code: LOD
• UDI-Device Identifier: 00190446138013
• UDI-Public: 00190446138013
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2023

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: 12/12/2021
• Device Model Number: 600-15-100
• Device Catalogue Number: 600-15-100
• Device Lot Number: 950C1D0043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male