MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; MODULAR COLLAR CEMENTED SEGMENTAL STEM, 17X120MM

Model Number	HC-17120-03M
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is in process.When the investigation is complete, a supplemental mdr will be submitted accordingly.
Event or Problem Description
The patient underwent a revision surgery on (b)(6) 2023 due to a suspected loosening of their 17x120mm modular collar cemented segmental stem.During the revision surgery, the patient's distal femoral replacement system was revised to a total femoral replacement system.During the revision surgery, the patient's modular collar cemented segmental stem was explanted and a male-female midsection, male-male midsection, and proximal femur were implanted.No additional information regarding this adverse event has been provided.
Additional Manufacturer Narrative
This report is being submitted to include additional information.The investigation is complete.The device was not returned for evaluation.The device history records and sterilization batch records were reviewed and there were no non-conformances identified that would have contributed to this complaint.If additional information is obtained, a supplemental mdr will be filed accordingly.The following sections were updated: 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 4110: trend analysis; h6: type of investigation code updated to 4109: historical data analysis; h6: investigation findings code updated to 3221: no findings available; h6: investigation conclusions code updated to 4315: cause not established;.
Event or Problem Description
The patient underwent a revision surgery on (b)(6) 2023 due to a suspected loosening of their 17x120mm modular collar cemented segmental stem.During the revision surgery, the patient's distal femoral replacement system was revised to a total femoral replacement system.During the revision surgery, the patient's modular collar cemented segmental stem was explanted and a male-female midsection, male-male midsection, and proximal femur were implanted.No additional information regarding this adverse event has been provided.

• Brand Name: ELEOS
• Common Device Name: MODULAR COLLAR CEMENTED SEGMENTAL STEM, 17X120MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): PHILLIPS PRECISION INC; 7 paul kohner pl; elmwood park NJ 07407
• Manufacturer Contact: sara dailey ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 17302414
• Report Number: 3013450937-2023-00121
• Device Sequence Number: 7061874
• Product Code: KRO
• UDI-Device Identifier: B278HC1712003M0
• UDI-Public: B278HC1712003M0
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K203815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 09/08/2023

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 Model Number: HC-17120-03M
• Device Catalogue Number: HC-17120-03M
• Device Lot Number: 84551-003
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: P/N 25000009E, ELEOS DISTAL FEMUR; P/N 25001040E, ELEOS MALE FEMALE MIDSECTION; P/N 25001090E, ELEOS MALE FEMALE MIDSECTION; P/N 25001208E, ELEOS TIBIAL POLY SPACER; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N HR-30001-03M, ELEOS COLLAR LOCKING RING; P/N KSP15100E, ELEOS STEM EXTENSION; P/N PB-3600R-03M, ELEOS BIOGRIP COLLAR; P/N TB-2204E-01M, ELEOS TIBIAL BASEPLATE; P/N TB-TSCRW-01M, ELEOS TIBIAL BASEPLATE SCREW; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 38 YR
• Patient Sex: Female