MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; STRAIGHT CEMENTED SEGMENTAL STEM, 13X120MM

Model Number	CS-13120-03M
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/02/2023
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 13x120mm straight cemented segmental stem.During the revision surgery, the patient's proximal femoral replacement system was revised to a total femoral replacement system.No additional information regarding this adverse event has been provided.
Additional Manufacturer Narrative
The patient underwent a revision surgery on (b)(6) 2023 due to a suspected loosening of their 13x120mm straight cemented segmental stem.During the revision surgery, the patient's proximal femoral replacement system was revised to a total femoral replacement system.During the revision surgery, the patient's cemented straight segmental stem was explanted and stem extension cemented, tibial baseplate tapered screw, tibial baseplate, tibial polyspacer, tibial hinge with rotational stop, distal femur axial pin, distal femur, two (2) male-female midsections, and male-male midsection were implanted.A review of the work order and sterilization batch release record for the product involved found no indication that the implant loosening was a result of a manufacturing or sterilization nonconformance.The eleos complaint history record was reviewed, which found three previous complaints for cemented segmental stem loosenings.Therefore, a complaint trend was not identified.The root cause for the cemented segmental stem loosening could not be determined.Based upon the review of the device history records and sterilization records, the investigation concluded that the root cause of the cemented segmental stem loosening was not related to the design, manufacturing, and/or sterilization of the components.

• Brand Name: ELEOS
• Common Device Name: STRAIGHT CEMENTED SEGMENTAL STEM, 13X120MM
• 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: vandita patel ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 17666908
• Report Number: 3013450937-2023-00186
• Device Sequence Number: 17704061
• Product Code: KRO
• UDI-Device Identifier: B278CS1312003M0
• UDI-Public: B278CS1312003M0
• 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: 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): 08/31/2023

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: CS-13120-03M
• Device Catalogue Number: CS-13120-03M
• Device Lot Number: 85222
• 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: 08/01/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2019
• 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 25001070E, ELEOS MALE FEMALE MIDSECTION; P/N 26012802E, ELEOS FEMORAL HEAD; P/N PF-2000R-02M, ELEOS PROXIMAL FEMUR
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female