MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; RESURFACING FEMUR, SIZE 3, LEFT

Model Number	2500L003E
Medical Device Problem Codes	Fracture (1260); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2022 due to the boss of the resurfacing femur cracking.This fracture resulted in an incomplete surface to accept the morse taper of the stem extension resulting in the two implants dissociating.During the revision surgery, the following eleos implants were revised: resurfacing femur, resurfacing femur axial pin, tibial hinge component, and tibial poly spacer.No additional information regarding this adverse event has been provided.
Additional Manufacturer Narrative
The investigation is in process.When the investigation is complete, a supplemental mdr will be submitted accordingly.Multiple mdrs were submitted for this event: #3013450937-2022-00075.
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 implant fracture could not be determined.The device history records and sterilization batch records were reviewed and no issues during manufacturing or sterilization were identified that would 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 3252: fracture problem.H6: investigation conclusions code updated to 4315: cause not established.H10: additional narratives/data.
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2022 due to the boss of the resurfacing femur cracking.This fracture resulted in an incomplete surface to accept the morse taper of the stem extension resulting in the two implants dissociating.During the revision surgery, the following eleos implants were revised: resurfacing femur, resurfacing femur axial pin, tibial hinge component, and tibial poly spacer.No additional information regarding this adverse event has been provided.

• Brand Name: ELEOS
• Common Device Name: RESURFACING FEMUR, SIZE 3, LEFT
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline road; arlington TN 38002
• Manufacturer Contact: sara dailey ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 13501765
• Report Number: 3013450937-2022-00074
• Device Sequence Number: 17141725
• Product Code: KRO
• UDI-Device Identifier: B2782500L003E0
• UDI-Public: B2782500L003E0
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• 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): 04/12/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2026
• Device Model Number: 2500L003E
• Device Catalogue Number: 2500L003E
• Device Lot Number: 1751249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2018
• 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: P/N 25001040E, ELEOS MALE-FEMALE MIDSECTION.; P/N 25001208E, ELEOS TIBIAL POLY SPACER.; P/N 25002100E, ELEOS TIBIAL HINGE COMPONENT.; P/N 25002113E, ELEOS RESURFACING FEMUR AXIAL PIN.; P/N 25002200E, ELEOS PROXIMAL TIBIA.; P/N CS-15120-03M, ELEOS CEMENTED SEGMENTAL STEM.; P/N KSP18140E, ELEOS CANAL-FILLING STEM EXTENSION.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 97 KG