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

Model Number	600-15-000
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/27/2021
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
Primary surgery - surgeon is concerned because the cement was rock hard in 7:38 minutes.He has been a cobalt cement user since biomet brought it to market.The room was 64 degrees, cement opened at the time of the case and was not warmed up in any way.This was a cemented hip and the stem ended up 5mm proud.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this primary surgery was reported as the uncontrolled temperature during transportation.The healthcare professional indicated that this event occurred during surgery, near the patient and there was a serious risk event to the patient and there was no delay in surgery and the surgery was completed as intended.The agent was present during surgery and was able to source a replacement after the reported complaint.The device was left in patient and not made available to djo surgical for examination.A review of the receiver revealed, when released for use, the product met design and manufacturing requirements.There was no non-conforming material report (ncmr) associated with the production lot that is related to the reported issue.Complaint database was reviewed and showed no previous complaints that allege this same issue.The root cause of this complaint is likely due to the uncontrolled temperature during transportation.No other information was submitted with the complaint regarding the condition of the cement.There are multiple factors that may have contributed to the event that is outside of the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: COBALT
• Common Device Name: COBALT HV BONE CEMENT 40GM
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758 6313
• Manufacturer (Section G): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758 6313
• Manufacturer Contact: kiersten soderman ; 9800 metric blvd.; austin 78758 ; 5128346250
• MDR Report Key: 11878085
• Report Number: 1644408-2021-00470
• Device Sequence Number: 19114624
• Product Code: LOD
• UDI-Device Identifier: 00190446138006
• UDI-Public: (01)00190446138006
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 11/25/2021

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: 09/24/2021
• Device Model Number: 600-15-000
• Device Catalogue Number: 600-15-000
• Device Lot Number: 939D1D0042
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2019
• 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; Other
• Patient Age: 72 YR
• Patient Sex: Female