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

Catalog Number	600-15-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Date of Event	04/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to pain and loosening.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Additional Manufacturer Narrative
The reason for this revision surgery, the agent reported "(patient received a nexgen non-augmentable tibia.Patient came back to the office with knee pain.During revision tibial implant was found to be grossly loose with no cement adhered to titanium surface.Age-73/gender -female)." the previous surgery and the surgery detailed in this event occurred 5.8 years apart.This evaluation is limited in scope as the item(s) associated with this investigation was not returned to djo surgical - austin for examination.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.There were no findings during this evaluation that indicate that the reported device(s) was defective.No further action is deemed necessary.A review of the device history record(s) show that the reported component(s) used in the previous surgery, when released for use, met design and manufacturing requirements.There were no nonconforming material reports associated with the product(s) that may have contributed to the reported event.The device(s) were within its expiration date at the time of the previous surgery.Customer complaint history of the reported device(s) showed no present trends or on-going issues that are needing a review.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.The revision surgery was completed successfully.The root cause of this complaint was a revision surgery due to the implant being grossly loose with no cement adhered to it.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event.There are multiple factors that may contribute to an event that 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: 19320359
• Report Number: 1644408-2024-00696
• Device Sequence Number: 7668856
• 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 Implanted Year: 2018
• Device Explanted Year: 2024
• 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): 08/17/2024

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: 06/30/2019
• Device Catalogue Number: 600-15-100
• Device Lot Number: 427280
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 08/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 600-15-100 LOT: 253710.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female