MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CEMENTED STEM, 15X152MM, BOWED, FLUTED, 32MM COLLAR

Model Number	CB-15152-03M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fall (1848)
Date of Event	06/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for investigation as it remains implanted.The investigation is in progress.When the investigation is complete, a supplemental report will be submitted accordingly.Multiple mdrs were reported for this event: #3013450937-2021-00133.#3013450937-2021-00134.#3013450937-2021-00136.#3013450937-2021-00137.#3013450937-2021-00138.#3013450937-2021-00139.
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2021.The patient fell due to an unknown reason which resulted in their incision opening.During the revision surgery, the following implants did not appear to be damaged: tibial hinge component, cemented stem 11x152mm, cemented stem 15x152mm, distal femur axial pin, proximal tibial, distal femur, and tibial poly spacer.A washout was performed and no parts were replaced.No additional information regarding this event has been obtained.
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2021.The patient fell due to an unknown reason which resulted in their incision opening.During the revision surgery, the following implants did not appear to be damaged: tibial hinge component, cemented stem 11x152mm, cemented stem 15x152mm, distal femur axial pin, proximal tibial, distal femur, and tibial poly spacer.A washout was performed and no parts were replaced.No additional information regarding this event has been obtained.
Additional Manufacturer Narrative
This report is being submitted to include additional information.The investigation is complete.The device was not returned for evaluation.The root cause of the patient 's fall could not be determined.The device history records and sterilization batch records were reviewed and no issues during manufacturing or sterilization were identified that could have contributed to this complaint.If any additional information is obtained, a supplemental mdr will be filed accordingly.The following sections were updated: b4: date of this report added.G3: date received by manufacturer added.G6: type of report added.H2: follow-up type added.H3: device evaluated by manufacturer updated to no.H6: type of investigation code updated to 3331: analysis of production records.H6: type of investigation code updated to 4111: communication/interviews.H6: type of investigation code updated to 4110: trend analysis.H6: type of investigation code updated to 4114: device not returned.H6: type of investigation code updated to 4117: device not accessible for testing.H6: type of investigation code updated to 4109: historical data analysis.H6: investigation findings code updated to 213: no device problem found.H6: investigation conclusions code updated to 4315: cause not established.H10: additional narratives/data.

• Brand Name: ELEOS
• Common Device Name: CEMENTED STEM, 15X152MM, BOWED, FLUTED, 32MM COLLAR
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey rd; parsippany NJ 07054
• MDR Report Key: 12124887
• Report Number: 3013450937-2021-00135
• Device Sequence Number: 11986635
• Product Code: KRO
• UDI-Device Identifier: B278CB1515203M0
• UDI-Public: B278CB1515203M0
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• 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: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2021

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: 03/04/2024
• Device Model Number: CB-15152-03M
• Device Catalogue Number: CB-15152-03M
• Device Lot Number: 82284
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 08/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: P/N 25000007E, ELEOS DISTAL FEMUR; P/N 25001210E, ELEOS TIBIAL POLY SPACER; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N 25002200E, ELEOS PROXIMAL TIBIA; P/N CB-11152-03M, ELEOS CEMENTED STEM 11X152MM; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT; SMITH&NEPHEW, P/N 71271590 BONE CEMENT
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 75 YR