MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CANAL-FILLING STRAIGHT SEGMENTAL STEM, 17X120MM

Model Number FS-17120-03M

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Joint Laxity (4526); Insufficient Information (4580)

Event Date 08/14/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is in process.When the investigation is complete, a supplemental mdr will be submitted accordingly.

Event Description

The patient underwent a revision surgery on (b)(6) 2023 due to a suspected loosening of their 17x120mm straight canal-filling segmental stem.During the revision surgery, the patient's 17x120mm straight canal-filling segmental stem was revised to a 20x120mm straight canal-filling segmental stem.The following eleos implants were also revised: distal femur, distal femur axial pin, tibial hinge component, tibial baseplate, cemented stem extension, tibial block augments, and tibial poly spacer.There were no reported malfunctions of the distal femur, distal femur axial pin, tibial hinge component, tibial baseplate, cemented stem extension, tibial block augments, and tibial poly spacer.No additional information regarding this adverse event have been reported.

Manufacturer Narrative

The patient underwent a revision surgery on (b)(6) 2023 due to a suspected loosening of their 17x120mm straight canal-filling segmental stem.During the revision surgery, the patient's 17x120mm straight canal-filling segmental stem was revised to a 20x120mm straight canal-filling segmental stem.The following eleos implants were also revised: distal femur, distal femur axial pin, tibial hinge component, tibial baseplate, cemented stem extension, tibial block augments, and tibial poly spacer.There were no reported malfunctions of the distal femur, distal femur axial pin, tibial hinge component, tibial baseplate, cemented stem extension, tibial block augments, and tibial poly spacer.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 23 previous complaints for canal filling segmental stem loosenings.The root cause for the canal filling 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 canal filling segmental.

• Brand Name: ELEOS
• Type of Device: CANAL-FILLING STRAIGHT 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: vandita patel ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 17712118
• MDR Text Key: 322977552
• Report Number: 3013450937-2023-00203
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278FS1712003M0
• UDI-Public: B278FS1712003M0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2024
• Device Model Number: FS-17120-03M
• Device Catalogue Number: FS-17120-03M
• Device Lot Number: 81697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 10/17/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: P/N 25000007E, ELEOS DISTAL FEMUR; P/N 25001216E, ELEOS POLY SPACER; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N KSC01530E, ELEOS STEM EXTENSION; P/N KTAGB415E, ELEOS TIBIAL BLOCK AUGMENT; P/N KTAGB415E, ELEOS TIBIAL BLOCK AUGMENT; P/N TB-2204E-01M, ELEOS TIBIAL BASEPLATE; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male