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

Model Number	600-15-000
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/13/2021
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
Revision surgery - infected removed all in 2 stage cement spacer inserted.
Additional Manufacturer Narrative
1644408-2021-01138 was reassessed and determined to be non-reportable.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as infection.The previous revision surgery (1st stage) and the revision surgery (2nd stage) detailed in this event occurred 2 days apart.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at hospital and not made available to djo surgical for examination.This investigation was the second stage of a two stage process to alleviate a patient previous infection.This complaint was to remove an antibiotic construct and replace them with new components.There was no product problem, and the surgery were completed as intended, no further action is necessary.Upon determination that the infection is under control and the tissue is normalized, the construct is removed and new components are implanted.There was no new information regarding cultures identified in the infection, severity of the infection or any patient activities, accidents, or medical contraindications that may have contributed to the previous infection.This event is not the result of a product deficiency, failure or issue.The surgery was completed as intended and without incident.No further action is deemed necessary.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Second revision surgery: infected removed all in 2 stage cement spacer inserted.

• Brand Name: BONE CEMENT
• Common Device Name: COBALT HV BONE CEMENT 40GM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer Contact: kiersten soderman ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 12686421
• Report Number: 1644408-2021-01138
• Device Sequence Number: 4012681
• 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: 2021
• Device Explanted 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,Followup
• Report Date (Section B): 12/23/2021

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: 02/02/2023
• Device Model Number: 600-15-000
• Device Catalogue Number: 600-15-000
• Device Lot Number: 105D1D0047
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2021
• Supplement Date Received by Manufacturer: 11/23/2021; 12/21/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 12/20/2021; 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2021
• 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: 80 YR
• Patient Sex: Male